Inspection device

Abstract

The present invention provides an inspection device that holds a plurality of test specimens, is small in size, and can accurately perform endotoxin or (1→3)-β-D-glucan inspections by various inspection methods. The inspection device (10) includes: a test specimen (21) having a circular cross-section that houses an inspection object (13); a test specimen holding unit (22) that holds a plurality of test specimens (21) in a row; light-emitting elements (62, 63) that emit light to two adjacent test specimens (21) among the plurality of test specimens (21); a first light guide path (46) that guides the light emitted by the light-emitting elements (62, 63); and a second light guide path (47) that is formed to have a diameter smaller than that of the first light guide path (46) and guides the light emitted by the light-emitting elements (62, 63) from the first light guide path (46) to the test specimen (21).

Description

Technical Field

[0001] The present invention relates to an inspection apparatus for inspecting a specimen using light. Background Art

[0002] Endotoxins present in the cell walls of Gram-negative bacteria, even in extremely small amounts on the order of nanograms to picograms, can cause various in-vivo reactions such as fever when mixed into the blood. Moreover, endotoxins have high heat resistance, and it is difficult to inactivate endotoxins even by autoclaving to kill Gram-negative bacteria. Therefore, for pharmaceuticals such as injectables and medical devices that may be contaminated with endotoxins in the blood, it is necessary to conduct inspections to confirm that they are not contaminated with endotoxins. Also, when a human or animal is infected with Gram-negative bacteria, endotoxins are produced in the body and remain in the blood. There is also a use for selecting a treatment method by collecting blood or body fluid from such a human or animal and inspecting for the presence of endotoxins.

[0003] Using the property of causing the aggregation of the hemocyte extract of horseshoe crabs, an endotoxin inspection is performed using a lysate reagent (so-called Limulus reagent) prepared from the hemocyte extract of horseshoe crabs. Also, inspection apparatuses for performing endotoxin inspections are known (Patent Documents 1 to 3). In addition, by adjusting the reagent components, a lysate reagent prepared from the hemocyte extract of horseshoe crabs can also be used for the determination of (1→3)-β-D-glucan present in the cell walls of fungi.

[0004] Prior Art Documents

[0005] Patent Documents

[0006] Patent Document 1: Japanese Patent Laid-Open No. 9-159671

[0007] Patent Document 2: Japanese Patent Laid-Open No. 2014-215298

[0008] Patent Document 3: Japanese Patent Laid-Open No. 2011-002379 Summary of the Invention

[0009] Technical Problem to be Solved by the Invention

[0010] An inspection apparatus for performing an endotoxin inspection (including inspections for measuring (1→3)-β-D-glucan in addition to inspections for measuring endotoxins; the same applies hereinafter) arranges a plurality of test bodies and performs these inspections sequentially or simultaneously. Also, as methods for inspecting endotoxins, in addition to the gelation method, there are also colorimetric methods and turbidimetric methods. Therefore, depending on the characteristics of the specimens held by each test body, these inspection methods are selected or combined to perform an endotoxin inspection. Also, for colorimetric methods, in order to appropriately select the wavelength of light used in the inspection, an inspection apparatus for performing an endotoxin inspection sometimes preliminarily includes a plurality of light-emitting elements.

[0011] As described above, in order to perform endotoxin inspection on a plurality of test specimens by various inspection methods, it is necessary to have a plurality of light-emitting elements with different emission wavelengths with respect to one test specimen. Therefore, there is a problem of increasing the size of the inspection apparatus. In addition, the optical components for guiding the light emitted from the light-emitting element to the test specimen are the main cause of the increase in the size of the inspection apparatus. However, if such optical components are simplified, other problems such as a decrease in inspection accuracy may occur.

[0012] An object of the present invention is to provide an inspection apparatus that holds a plurality of test specimens, is small in size, and can accurately perform endotoxin or (1→3)-β-D-glucan inspection by various inspection methods.

[0013] Means for Solving the Technical Problem

[0014] The inspection apparatus of the present invention includes: a test specimen having a circular cross section that houses an object to be inspected; a test specimen holding unit that holds a plurality of test specimens in a row; a light-emitting element that irradiates light to two adjacent test specimens among the plurality of test specimens held by the test specimen holding unit; a first light guide path that guides the light emitted from the light-emitting element; and a second light guide path that is formed thinner than the first light guide path and guides the light emitted from the light-emitting element from the first light guide path to the test specimen.

[0015] Preferably, the first light guide path is commonly provided for a plurality of light-emitting elements.

[0016] Preferably, the second light guide path has a through hole parallel to the direction connecting the light-emitting element and the test specimen.

[0017] Preferably, a plurality of plates having through holes are arranged on the second light guide path, and the plates transmit light in a direction parallel to the direction connecting the light-emitting element and the test specimen and orthogonal to the arrangement direction of the test specimens in the test specimen holding unit.

[0018] Preferably, a light-receiving element for receiving the light transmitted or scattered by the test specimen is provided for each test specimen.

[0019] Preferably, the light-emitting element irradiates light from an inclined direction with respect to the direction connecting the light-receiving element and the test specimen.

[0020] Preferably, the light-receiving element has a shielding member that restricts the incidence of light, and receives the light transmitted or scattered by the test specimen through an opening provided in the shielding member.

[0021] Preferably, the opening has a shape that is longer in the arrangement direction of the light-emitting elements.

[0022] Preferably, the opening is provided with a color filter that selectively transmits the light emitted from the light-emitting element.

[0023] Preferably, the opening is divided into a plurality of regions, and each region is further provided with a color filter having a different color of the transmitted light.

[0024] Preferably, as the light-emitting elements, there are provided a first-color light-emitting element that emits light of a first color and a second-color light-emitting element that emits light of a second color different from the first color. In the arrangement of the plurality of light-emitting elements, the first-color light-emitting elements and the second-color light-emitting elements are alternately arranged.

[0025] Preferably, in addition to the light-emitting elements, a third-color light-emitting element is further provided between the first-color light-emitting element and the second-color light-emitting element. The third-color light-emitting element emits light of a third color different from the first color and the second color, and light is incident from a direction orthogonal to the arrangement direction of the test specimens in the test specimen holding unit that connects the light-receiving element and the test specimens.

[0026] Another inspection device of the present invention includes a plurality of measurement units, and each measurement unit includes: a test specimen having a circular cross-section that houses an inspection object; a test specimen holding unit that holds a plurality of test specimens in a row; a light-emitting element that irradiates light to two adjacent test specimens among the plurality of test specimens; a first light guide path that guides the light emitted by the light-emitting element; and a second light guide path that is formed to have a diameter smaller than that of the first light guide path and guides the light emitted by the light-emitting element from the first light guide path to the test specimens.

[0027] Advantages of the Invention

[0028] The inspection device of the present invention holds a plurality of test specimens, is small in size, and can accurately perform the inspection of endotoxin or (1→3)-β-D-glucan by various inspection methods. BRIEF DESCRIPTION OF THE DRAWINGS

[0029] Figure 1 It is a block diagram showing the structure of the inspection device.

[0030] Figure 2 It is a perspective view of the measurement unit and the test specimens.

[0031] Figure 3 It is an XZ cross-sectional view of the measurement unit.

[0032] Figure 4 It is an XY cross-sectional view of the measurement unit.

[0033] Figure 5 It is an explanatory view showing the structure of a shielding member provided on the light-receiving surface of the light-receiving element.

[0034] Figure 6 It is an explanatory view showing the structure of another shielding member.

[0035] Figure 7 It is an explanatory view showing an example of providing a color filter on the light-receiving surface of the light-receiving element.

[0036] Figure 8 It is an explanatory view showing an example of providing a color filter on the light-receiving surface of the light-receiving element.

[0037] Figure 9 It is an XY cross-sectional view of the measurement unit of the second embodiment. Detailed implementation mode

[0038] [First Embodiment]

[0039] As Figure 1 shown, the inspection device 10 includes a device main body 11 and a computer 12. The inspection device 10 inspects for contamination caused by endotoxin by performing optical measurement on an inspection object 13 (refer to Figure 2 ), and measures the content or concentration of endotoxin as needed. The inspection object 13 is a solution such as a mixed lysis reagent and a test substance. The test substance and the like are, for example, injections such as vaccines or blood preparations, or water, polyethylene glycol, ethylenediaminetetraacetic acid, etc. (so-called recovery solution) obtained by recovering endotoxin from test substances such as syringes or injection needles, or blood or body fluids collected from patients who may be infected with Gram-negative bacteria or fungi. The lysis reagent is LAL (Limulus Amebocyte Lysate) or TAL (Tachypleus Amebocyte Lysate).

[0040] In addition, by adjusting the reagent components, the lysis reagent prepared from the horseshoe crab blood cell extract can also be used for the determination of (1→3)-β-D-glucan present in the cell wall of fungi. The lysis reagent is used for the inspection of determining the presence or absence of fungal infection by measuring the concentration of (1→3)-β-D-glucan in the patient's blood or body fluid. In this specification, when it is described as endotoxin, it can be replaced with (1→3)-β-D-glucan, and the inspection device 10 for endotoxin inspection also functions as an inspection device for (1→3)-β-D-glucan. And, it is possible to perform the inspections of both endotoxin and (1→3)-β-D-glucan by one inspection device 10.

[0041] The device main body 11 is the part of the inspection device 10 that includes a measurement unit 15 for performing optical measurement of a specimen. Specifically, the device main body 11 includes a test body 21, a test body holding part 22, a light emitting part 23, a light guiding part 24, a light detecting part 26, a display part 27, an operation part 28, etc. Among these, the test body holding part 22, the light emitting part 23, the light guiding part 24, and the light detecting part 26 constitute the measurement unit 15.

[0042] The test body 21 is a container with a circular cross-section that houses the object to be inspected 13. In the present embodiment, the state in which the object to be inspected is housed is also simply referred to as the test body 21. The circular cross-section means that when the part that houses the object to be inspected 13 (especially the part irradiated with light for inspection) is horizontally cut in the state of being disposed in the apparatus main body 11, the outer shape of its cross-section is a circle, an ellipse, or a substantially smooth closed curve similar thereto. In the present embodiment, as Figure 2 shown, the test body 21 is substantially cylindrical. Further, the test body 21 is made of heat-resistant glass. This is to ensure that, for example, through dry heat sterilization treatment at 250 degrees or more for 30 minutes or more, the test body 21 before housing the object to be inspected does not contain endotoxin and (1→3)-β-D-glucan.

[0043] The test body holding part 22 holds a plurality of test bodies 21 side by side. The test body holding part 22 has a plurality of openings 31 arranged in a row (refer to Figure 2 ). Thus, by inserting the test bodies 21 into the respective openings 31, the test body holding part 22 holds the plurality of test bodies 21 arranged in a row. In the present embodiment, the test body holding part 22 has 10 openings 31, and by inserting the test bodies 21 into all of these openings, 10 test bodies 21 can be held simultaneously. Additionally, the test body holding part 22 may hold 11 or more or 9 or fewer test bodies 21. Moreover, the test body holding part 22 has a heater 32 on the bottom surface (the surface on the negative Z direction side). By controlling the conduction and disconnection of the heater 32, the temperature of the test body holding part 22 and the test bodies 21 held by the test body holding part 22 can be maintained at a specified temperature or within a specified temperature range. Therefore, the test body holding part 22 also functions as a so-called constant temperature bath.

[0044] The light emitting part 23 irradiates the test bodies 21 held by the test body holding part 22 with light for inspection. As Figure 3 shown, the light emitting part 23 includes a light emitting element 41. The light emitting element 41 is, for example, an LED (light emitting diode), and by emitting light, light 42 for inspection is incident on the test body 21. Further, the light emitting element 41 emits light in a wide range such that it can irradiate at least two or more test bodies 21 with light 42. Since the light emitting element 41 emits light 42 to a plurality of measurement sites (a plurality of test bodies 21), it is preferably a diffused light source that can obtain substantially the same amount of light with respect to the directions in which the respective measurement sites (respective test bodies 21) are located.

[0045] The light guiding part 24 guides the light 42 emitted by the light emitting element 41 to the test bodies 21 held by the test body holding part 22. Specifically, the light guiding part 24 has a first light path 46 and a second light path 47 (refer to Figure 3 ).

[0046] The first light guide path 46 is the part of the light guide portion 24 that is relatively located on the side of the light emitting element 41, and has an opening 48 at the connection portion with the light emitting portion 23. And when the light emitting portion 23 is connected to the light guide portion 24, the light emitting element 41 is exposed to the first light guide path 46 through the opening 48. Therefore, the first light guide path 46 is a space that directly receives the light 42 generated by the light emitting element 41 and propagates it to the second light guide path 47. In the present embodiment, the first light guide path 46 is a space 49 filled with air and capable of ventilating with the outside. However, if necessary, a dielectric material or the like may be filled in a part or all of the space 49. The first light guide path 46 is used to guide the light 42 of the light emitting element 41 that emits light in a wide range toward at least two or more adjacent test bodies 21.

[0047] The second light guide path 47 is formed to be relatively thinner in diameter than the first light guide path 46, and guides the light 42 emitted from the light emitting element 41 from the first light guide path 46 to the test body 21. Specifically, the second light guide path 47 is the part of the light guide portion 24 that is relatively located on the side of the test body holding portion 22, and has a through hole 51 at the connection portion with the test body holding portion 22. The through hole 51 is a through hole parallel to the direction connecting the light emitting element 41 and the test body 21. And in the test body holding portion 22, an opening 52 is provided at a position where at least the through hole 51 of the second light guide path 47 is exposed to the test body 21. Therefore, among the light 42 propagating in the space 49 of the first light guide path 46, the light 42 incident on the through hole 51 of the second light guide path 47 enters the test body 21 through the opening 52.

[0048] "Relatively thinner than the first light guide path 46 in diameter" means that at the connection portion between the through hole 51 and the space 49, the diameter (cross-sectional area in the YZ direction) of the through hole 51 of the second light guide path 47 is smaller than the diameter (cross-sectional area in the YZ direction) of the space 49 of the first light guide path 46. Also, the through hole 51 of the second light guide path 47 is longer in the X direction than the effective diameter of the opening (light 42 incident port) on the space 49 side. That is, the through hole 51 is not a simple plane but has a substantial thickness in the in-plane direction of the XY plane. Thereby, the second light guide path 47 restricts the incident angle of the light 42 from the space 49 side with respect to the through hole 51 and the exit angle of the light 42 from the through hole 51 toward the test body 21 side. As a result, the second light guide path 47 prevents the light 42 reflected, etc. in the space 49 from entering the through hole 51 at a wide angle and the light 42 from exiting the through hole 51 at a wide angle and entering the test body 21. Also, the second light guide path 47 suppresses the incident light from a light-emitting element different from the light-emitting element 41 that emits light in a wide range and is opposed to it from passing through the second light guide path 47, and suppresses the reflected light that may be generated in the case of passing through from entering the test body 21 and generating a false signal. That is, the second light guide path 47 makes the light 42 incident on the test body 21 only the light from the opposed light-emitting element 41 and further restricts it to substantially parallel light. Also, the through hole 51 is provided at a position away from the light-emitting element 41 with the space 49 interposed therebetween, which also helps to make the light 42 incident on the test body 21 substantially parallel light. Substantially parallel light means light that maintains the parallelism to the extent of passing directly through the through hole from the light-emitting element.

[0049] The light detection unit 26 includes a light-receiving element 53 that receives the light transmitted or scattered by the test body 21. The light-receiving element 53 is a light sensor such as a PD (Photo Diode), for example, and is provided for each test body 21. In the present embodiment, since the test body holding unit 22 holds 10 test bodies 21, the light detection unit 26 includes the light-receiving element 53 at positions where it can receive the light 42 transmitted through these respective test bodies 21. Also, the test body holding unit 22 has an opening 54 between the test body 21 and the light-receiving element 53, and the opening 54 has a range that at least exposes the light-receiving element 53 to the test body 21 side. Therefore, the light 42 after being transmitted, etc. through the test body 21 reaches the light-receiving element 53 via the opening 54.

[0050] As Figure 4As shown, the light-emitting unit 23 includes, in addition to the light-emitting element 41, light-emitting elements 62 and 63 that emit light in a wavelength band different from that of the light-emitting element 41. The light-emitting elements 62 and 63 emit light in a wide range such that they can irradiate at least two or more test specimens 21 with light. Thus, since the light-emitting elements 62 and 63 emit light to a plurality of measurement sites (a plurality of test specimens 21), it is preferably a diffused light source that can obtain substantially the same amount of light with respect to the direction in which each measurement site (each test specimen 21) is located. Also, there are a plurality of the light-emitting elements 41, 62, and 63, and they are periodically arranged in the order of the light-emitting element 41, the light-emitting element 62, and the light-emitting element 63 along the X direction.

[0051] The light-emitting element 41 is disposed substantially in front of each light-receiving element 53 and the test specimen 21. In endotoxin inspection, the light-emitting element 41 irradiates the test specimen 21 located in front when viewed from the light-emitting element 41 with light 42 through the space 49 of the first light guide path 46 and the through hole 51 of the second light guide path 47. The light-emitting element 41 is used, for example, when performing an inspection based on turbidimetry, and the light 42 emitted from the light-emitting element 41 is, for example, red. In addition, the front refers to a position on the extension line of the normal line of the light-receiving surface of the light-receiving element 53 passing through the center of the test specimen 21.

[0052] The light emitted from the light-emitting element 62 is, for example, purple. And the light emitted from the light-emitting element 63 is, for example, blue. These light-emitting elements 62 and 63 are selectively used, for example, when performing an inspection based on colorimetry. And in the arrangement of the plurality of light-emitting elements, if we focus on the arrangement of the light-emitting elements 62 and 63, they are alternately arranged in the X direction. That is, in the measurement unit 15, as light-emitting elements, there are provided a light-emitting element 62 as a first-color light-emitting element that emits light of a first color (for example, purple) and a light-emitting element 63 as a second-color light-emitting element that emits light of a second color (for example, blue) different from the first color. In the arrangement of the plurality of light-emitting elements, the light-emitting element 62 as the first-color light-emitting element and the light-emitting element 63 as the second-color light-emitting element are alternately arranged. Thus, for any one of the plurality of test specimens 21 held by the test specimen holding unit 22, light can be incident from the light-emitting elements 62 and 63 respectively.

[0053] In addition, as described above, when the light-emitting elements 62 and 63 are the first-color light-emitting element and the second-color light-emitting element, the light-emitting element 41 is the third-color light-emitting element. That is, the measuring unit 15 has the light-emitting element 41 as the third-color light-emitting element between the light-emitting element 62 as the first-color light-emitting element and the light-emitting element 63 as the second-color light-emitting element. The light-emitting element 41 emits light of a third color (e.g., red) different from the first color and the second color (e.g., purple and blue), and the light is incident from the direction connecting the light-receiving element 53 and the test body 21 ( Figure 4 in the direction of the dotted line passing through the center of the test body 21 and connecting the light-receiving element 53 and the light-emitting element 41).

[0054] The light-emitting elements 62 and 63 are arranged at non-front positions of the light-receiving element 53 and the test body 21 (between the two light-emitting elements 41 (especially the midpoint)). Moreover, when the light-emitting elements 62 and 63 emit light respectively, light is simultaneously incident on two adjacent test bodies 21 among the plurality of test bodies 21 held by the test body holding portion 22. Therefore, the light-emitting elements 62 and 63 emit light from an inclined direction with respect to the direction connecting the light-receiving element 53 and the test body 21.

[0055] For the above usage mode, the first light guide path 46 is commonly provided for a plurality of light-emitting elements (the light-emitting elements 41, 62, and 63, each having a plurality). That is, the space 49 forming the first light guide path 46 is not divided for each test body 21 or the like, but forms a continuous region in the X direction. Therefore, the first light guide path 46 does not obstruct the propagation of light emitted by any of the light-emitting elements 41, 62, and 63, each having a plurality.

[0056] In addition, the second light guide path 47 has, in addition to the through hole 51 that guides the light 42 emitted by the light-emitting element 41, through holes 72L, 72R, 73L, and 73R that guide the light emitted by the light-emitting elements 62 and 63.

[0057] The through holes 72L and 72R are through holes parallel to the direction connecting the light-emitting element 62 and the test body 21. Therefore, the through hole 72L guides the light emitted by the light-emitting element 62 to the test body 21 located on the left side (negative X direction) when viewed from the light-emitting element 62. The through hole 72R guides the light emitted by the light-emitting element 62 to the test body 21 located on the right side (positive X direction) when viewed from the light-emitting element 62.

[0058] Similarly, the through-holes 73L and 73R are through-holes that are substantially parallel to the direction connecting the light-emitting element 63 and the test body 21. Therefore, the through-hole 73L guides the light emitted from the light-emitting element 63 to the test body 21 located on the left side (negative X direction) when viewed from the light-emitting element 63. The through-hole 73R guides the light emitted from the light-emitting element 63 to the test body 21 located on the right side (positive X direction) when viewed from the light-emitting element 63.

[0059] At the connection portion of the through-holes 72L, 72R, 73L, and 73R with the space 49, the diameters (cross-sectional areas in the YZ direction) of the through-holes 72L, 72R, 73L, and 73R are smaller than the diameter (cross-sectional area in the YZ direction) of the first light guide path 46. Therefore, for the through-holes 72L, 72R, 73L, and 73R, the diameter of the second light guide path 47 is also formed to be relatively thinner than the first light guide path 46, and the light emitted from the light-emitting elements 62 and 63 is guided from the first light guide path 46 to the test body 21. In addition, the opening 52 of the test body holding portion 22 exposes the through-holes 72L, 72R, 73L, and 73R to the test body 21. And the opening 54 of the test body holding portion 22 does not prevent the light incident on the test body 21 via the through-holes 72L, 72R, 73L, and 73R from reaching the light-receiving element 53.

[0060] Moreover, regarding the through-holes 72L, 72R, 73L, and 73R, they are longer than the effective diameter of the opening (light incident port) on the space 49 side in their extending directions, and these are not simple planes but have a substantial thickness. Therefore, the second light guide path 47 prevents the light reflected in the space 49, etc. from entering the through-holes 72L, 72R, 73L, and 73R at a wide angle and the situation where such light exits from the through-holes 72L, 72R, 73L, and 73R at a wide angle and enters the test body 21. That is, the second light guide path 47 also restricts the light incident on the test body 21 to substantially parallel light when using the light-emitting elements 62 and 63. And the through-holes 72L, 72R, 73L, and 73R are arranged at positions far from the light-emitting elements 62 and 63 with the space 49 therebetween, which also helps to make the light 42 incident on the test body into substantially parallel light.

[0061] The display unit 27 is, for example, an indicator that displays whether the inspection can be performed and / or the progress of the inspection, etc. And the display unit 27 can be a display screen such as a liquid crystal panel or a touch panel, etc.

[0062] The operation unit 28 is a switch or the like for directly giving an operation instruction to the apparatus main body 11. When the display unit 27 is a touch panel, at least a part of the operation unit 28 can be formed by using the graphical user interface displayed on the touch panel.

[0063] The computer 12 is a part that controls each part of the apparatus main body 11 in the inspection apparatus 10 and performs analysis or determination or the like by using the measurement data (signals obtained from the light receiving element 53, etc.) obtained from the apparatus main body 11. Specifically, the computer 12 obtains the measurement data from the measurement unit 15, and performs analysis or the like by using the measurement data, thereby determining the presence or absence of endotoxin or generating data capable of determining the presence or absence of endotoxin. In addition, in the present embodiment, the computer 12 is provided separately from the apparatus main body 11, but a part or all of the functions of the computer 12 can be incorporated into the apparatus main body 11.

[0064] In the inspection apparatus 10, endotoxin inspection based on colorimetry and turbidimetry can be performed. Colorimetry is an inspection method for measuring the activation of a lysis reagent by endotoxin through the absorbance at a specific wavelength, thereby determining the presence or absence of endotoxin or the like. In order to perform the inspection based on colorimetry, the measurement unit 15 includes two types of light emitting elements, a light emitting element 62 and a light emitting element 63. Therefore, depending on the characteristics of the inspection object 13 or the like, the endotoxin inspection is performed by using either the light emitting element 62 or the light emitting element 63. Turbidimetry is an inspection method for measuring the change in the turbidity of a sample gelled by the activation of a lysis reagent by endotoxin, thereby determining the presence or absence of endotoxin or the like. In the inspection based on turbidimetry, the light emitting element 41 provided for each test body 21 is used.

[0065] As described above, in order to perform endotoxin inspection based on turbidimetry and colorimetry, the inspection apparatus 10 includes three types of light emitting elements, a light emitting element 41, a light emitting element 62, and a light emitting element 63. However, the colorimetry light emitting elements 62 and 63 are arranged between two adjacent test bodies 21, and are configured to irradiate light from one of the light emitting elements 62 or 63 to both of the two adjacent test bodies 21. Therefore, compared with the case where a light emitting element 41, a light emitting element 62, and a light emitting element 63 are provided for each test body 21, the length in the X direction can be formed shorter, and miniaturization of the entire inspection apparatus 10 can be achieved. Moreover, even if a light emitting element 41 for turbidimetry is added to each test body 21 as in the first embodiment described above, miniaturization can be maintained.

[0066] Furthermore, the test body 21 is made of glass to withstand dry heat sterilization and has a circular cross section. Therefore, if light is incident on the test body 21 from an oblique direction, the light is reflected on the surface of the test body 21, and it is difficult for the light to be incident on the inspection object 13. As a result, the inspection accuracy may be reduced. For example, when the light for inspection is guided by an optical fiber or the like, or when the light is focused on the test body 21 through an aperture that does not substantially have a thickness, the amount of light that is expected to be incident on the test body 21 and the inspection object 13 is different from the amount of light that is actually incident on the test body 21 and the inspection object 13 due to a slight positional deviation of the test body 21. As a result, the inspection accuracy may be reduced. However, the inspection device 10 guides light to the test body 21 through the first light guide 46 and the second light guide 47, so that the light emitted by the light emitting element 62 or the light emitting element 63 can be incident on both of the two adjacent test bodies 21. On the other hand, the light incident on the test body 21 is narrowed by the through hole (through hole 72L, etc.) and adjusted to be substantially parallel light. Therefore, compared with the case of using an optical fiber or an aperture, it is easier to make a predetermined amount of light incident on the test body 21 and the inspection object 13. As a result, the inspection device 10 can hold a plurality of test bodies 21 and be compact, and can accurately perform endotoxin inspections using various inspection methods.

[0067] Furthermore, as described above, the inspection device 10 narrows the light incident on the test object 21 through the through hole (through hole 72L, etc.) and adjusts it to substantially parallel light, so even if the inspection object 13 is turbid from the beginning (before the reaction of endotoxin and the lysis reagent) due to the characteristics of the inspection object 13 (containing fat components, etc.), it is easy to make light of a predetermined brightness incident on the inspection object 13. Therefore, the inspection device 10 can perform endotoxin inspection with good accuracy.

[0068] In the first embodiment, the first light guide 46 (i.e., the inner surface forming the space 49 and the portion of the light emitting portion 23 other than the light emitting element 41) and the second light guide 47 (at least the surface (inner surface portion) forming the second light guide 47) are preferably as low-reflective as possible. Therefore, it is preferred that the first light guide 46 and the second light guide 47 are formed using a light-absorbing material or a surface coating. Therefore, the first light guide 46 and the second light guide 47 can be subjected to matte black alumina treatment or coated with black paint in advance, for example.

[0069] In addition, regarding the light receiving element 53 mounted on the inspection device 10 of the first embodiment, Figure 5As shown, it is preferable to provide a shielding member 81 that restricts the incidence of light on its light-receiving surface, and receive the light transmitted or scattered by the test body 21 through the opening 82 of the shielding member 81. This is to limit the reception of unwanted stray light or scattered light and improve the inspection accuracy. Also, the opening 82 provided in the shielding member 81 is preferably formed to be minimized according to the position, size, and shape of the spots of the light incident on the test body 21 from the light-emitting element 41, the light-emitting element 62, and the light-emitting element 63. For example, as Figure 6 shown, it is preferably a so-called stadium-shaped opening 82, and is formed in a shape that is longer in the arrangement direction (X direction) of the light-emitting element 41, the light-emitting element 62, and the light-emitting element 63, so as to substantially minimize the inclusion of the spot 86 reached by the light 42 emitted by the light-emitting element 41, the spot 87 reached by the light emitted by the light-emitting element 62, and the spot 88 reached by the light emitted by the light-emitting element 63. At this time, the reception of unnecessary light can be restricted with higher accuracy, and the inspection accuracy can be further improved. As a shape that is longer in the arrangement direction of the light-emitting elements, in addition to the above-mentioned stadium shape, there are an ellipse or a rectangle having a major axis in the arrangement direction of the light-emitting elements, etc.

[0070] As described above, when using the shielding member 81 having the opening 82 in the light-receiving element 53, it is preferable to provide a color filter in the opening 82 that selectively transmits the light emitted by the light-emitting element. In particular, it is preferable that the opening 82 is divided into a plurality of regions according to the position, size, and shape of the spots of the light incident on the test body 21 from the light-emitting element 41, the light-emitting element 62, and the light-emitting element 63, and a color filter having a different transmitted light color is provided in each region. Specifically, as Figure 7 shown, it is preferable to provide color filters 91 to 93 that selectively transmit the light emitted by the light-emitting element 41, the light-emitting element 62, and the light-emitting element 63. The color filter 91 selectively transmits the light 42 emitted by the light-emitting element 41. The color filter 92 selectively transmits the light (for example, purple light) emitted by the light-emitting element 62. The color filter 93 selectively transmits the light (for example, blue light) emitted by the light-emitting element 63. Thus, if the color filters 91 to 93 are provided in the opening 82, the inspection can be performed more accurately. This is because, for example, when using the light-emitting element 41, the size of the opening 82 is substantially limited to the portion where the color filter 91 is located, so it is difficult to receive the scattered light reaching the positions of the color filter 92 and the color filter 93. The same applies when using the light-emitting element 62 or the light-emitting element 63.

[0071] As Figure 8 shown, when the opening 82 is formed in a shape that is longer in the arrangement direction of the light-emitting elements other than the stadium shape, the color filters 91 to 93 can be provided in the opening 82. At this time, the outer dimension of the opening 82 is originally small, and the effective opening size is optimized by the color filters 91 to 93, so the inspection can be performed particularly accurately.

[0072] In addition, in the above-described modification, the color filters 91 to 93 are used for the opening 82 of the shielding member 81. However, by extending the color filters 91 to 93 to the end portion of the light-receiving surface of the light-receiving element 53, the shielding member 81 can be omitted. Moreover, in the above-described modification, the case where one light-receiving element 53 is provided for each test body 21 is taken as an example, but the number of light-receiving elements 53 can also be increased, and two or three light-receiving elements can be provided for each test body 21 according to the number of incident wavelengths (the types of light-emitting elements). At this time, the shielding member 81 is appropriately provided for each light-receiving element, and the color filters 91 to 93 are provided, thereby enabling further improvement of the measurement accuracy.

[0073] [Second Embodiment]

[0074] In the above-described first embodiment and modification, the second light guide path 47 having a substantial thickness in the XY-plane direction is formed by providing the through hole 51 and the like in one plate-like member, but the second light guide path 47 can be formed in other ways. For example, the second light guide path 47 can be configured to have a structure in which a plurality of plates having through holes (hereinafter, referred to as through hole plates) are arranged so that light penetrates parallel to the direction connecting the light-emitting element 41 and the like and the test body 21.

[0075] Specifically, as Figure 9 shown, a partition member 201 that separates the first light guide path 46 and the test body holding portion 22 is provided between the first light guide path 46 and the test body holding portion 22. In the partition member 201, openings 202 for guiding the light emitted from the light-emitting element 41, the light-emitting element 62, and the light-emitting element 63 to the test body 21 side are provided on the front side of each test body 21. And, in the opening 202, a first through hole plate 203 and a second through hole plate 204 are respectively provided before and after it (for example, one side of the light-emitting element 41 and the like and the opening end on the test body 21 side).

[0076] The first through hole plate 203 is provided on the front end side (one side of the light-emitting element 41 and the like) of the opening 202, and has a first through hole 211, a second through hole 212, and a third through hole 213. The first through hole 211 is located on the straight line connecting the light-emitting element 41 and the test body 21, the second through hole 212 is located on the straight line connecting the light-emitting element 62 and the test body 21, and the third through hole 213 is located on the straight line connecting the light-emitting element 63 and the test body 21.

[0077] And, the second through hole plate 204 is provided on the rear end side (one side of the test body 21) of the opening 202, and has a first through hole 221, a second through hole 222, and a third through hole 223. The first through hole 221 is located on the straight line connecting the light-emitting element 41 and the test body 21, the second through hole 222 is located on the straight line connecting the light-emitting element 62 and the test body 21, and the third through hole 223 is located on the straight line connecting the light-emitting element 63 and the test body 21.

[0078] As described above, when forming the second light guide path 47 by using the first through-hole plate 203 and the second through-hole plate 204, the first through-hole 211 of the first through-hole plate 203 and the first through-hole 221 of the second through-hole plate 204 substantially function the same as the through-hole 51 in the first embodiment. That is, the first through-hole 211 of the first through-hole plate 203 and the first through-hole 221 of the second through-hole plate 204 limit the incident angle of the light 42 emitted by the light-emitting element 41 and the exit angle of the light 42 toward the test body 21 side. On the other hand, different from the through-hole 51 in the first embodiment, the space between the first through-hole 211 of the first through-hole plate 203 and the first through-hole 221 of the second through-hole plate 204 is hollow, so that only the light 42 passing through them accurately and substantially straight reaches the test body 21. In the case of the through-hole 51 in the first embodiment, although very few, there is a possibility that the light reflected from the inner wall of the through-hole 51 generates a false signal. However, by forming the through-hole 51 in the first embodiment with the first through-hole 211 of the first through-hole plate 203 and the first through-hole 221 of the second through-hole plate 204 as described above, the incident angle of the light 42 emitted by the light-emitting element 41 and the exit angle of the light 42 toward the test body 21 side can be more accurately limited, and the generation of false signals can be more reliably suppressed.

[0079] Moreover, when forming the second light guide path 47 by using the first through-hole plate 203 and the second through-hole plate 204, the second through-hole 212 of the first through-hole plate 203 and the second through-hole 222 of the second through-hole plate 204 substantially function the same as the through-hole 72L (or through-hole 72R) in the first embodiment, limiting the incident angle of the light emitted by the light-emitting element 62 and the exit angle of the light toward the test body 21 side. The limitation of this incident angle and exit angle is more accurate than the through-hole 72L (or through-hole 72R) in the first embodiment, and the generation of false signals can be more reliably suppressed.

[0080] Similarly, when forming the second light guide path 47 by using the first through-hole plate 203 and the second through-hole plate 204, the third through-hole 213 of the first through-hole plate 203 and the third through-hole 223 of the second through-hole plate 204 substantially function the same as the through-hole 73L (or through-hole 73R) in the first embodiment, limiting the incident angle of the light emitted by the light-emitting element 63 and the exit angle of the light toward the test body 21 side. The limitation of this incident angle and exit angle is more accurate than the through-hole 73L (or through-hole 73R) in the first embodiment, and the generation of false signals can be more reliably suppressed.

[0081] In addition, in the second embodiment, the second light guide path 47 is formed by using the two through-hole plates, i.e., the first through-hole plate 203 and the second through-hole plate 204. However, the second light guide path 47 can also be formed by arranging through-hole plates identical to them between the first through-hole plate 203 and the second through-hole plate 204, so that the second light guide path 47 is formed by using three or more through-hole plates.

[0082] Moreover, as with the third through-hole plate 261 (refer to Figure 9 ), a through-hole plate identical to the above-mentioned first through-hole plate 203 and second through-hole plate 204 can be provided inside or at the end of the opening 54 having a range where the light-receiving element 53 is exposed to the test body 21 side. The third through-hole plate 261 has a first through-hole 271, a second through-hole 272, and a third through-hole 273. The first through-hole 271 is located on the straight line connecting the light-emitting element 41 and the test body 21, the second through-hole 272 is located on the straight line connecting the light-emitting element 62 and the test body 21, and the third through-hole 273 is located on the straight line connecting the light-emitting element 63 and the test body 21. Thus, when the third through-hole plate 261 is provided in the opening 54 provided on the front surface of the light-receiving element 53, light scattered by the test body 21 and / or the inspection object 13, etc. can be prevented from reaching the light-receiving element 53, and false signals can be more reliably suppressed.

[0083] In addition, Figure 9 in, the first through-hole 211, the second through-hole 212, and the third through-hole 213 of the first through-hole plate 203 are formed along the light traveling direction, and the second through-hole 212 and the third through-hole 213 are formed obliquely with respect to the first through-hole plate 203. However, the first through-hole 211, the second through-hole 212, and the third through-hole 213 (especially the second through-hole 212 and the third through-hole 213) of the first through-hole plate 203 can be formed perpendicular to the first through-hole plate 203. At this time, the first through-hole plate 203 is preferably a thin plate within a range that does not affect measurement and intensity, etc. The same applies to the second through-hole plate 204 and its first through-hole 221, second through-hole 222, and third through-hole 223, and the third through-hole plate 261 and its first through-hole 271, second through-hole 272, and third through-hole 273.

[0084] Moreover, Figure 9 in, the first through-hole plate 203, the second through-hole plate 204, and the third through-hole plate 261 are respectively and independently provided for each test body 21, but they can also be provided together for a plurality of test bodies 21. That is, a plurality of first through-hole plates 203 can be integrally formed. The same applies to the second through-hole plate 204 and the third through-hole plate 261.

[0085] In the second embodiment described above, regarding the structures other than the second light guide path 47, they can be arbitrarily combined with those of the first embodiment and the modified example of the first embodiment.

[0086] In addition, in the first embodiment, the second embodiment, and the modified examples thereof, the inspection device 10 performs endotoxin inspection based on turbidimetry and colorimetry. However, when only performing inspection based on turbidimetry, the structures related to the colorimetric inspection (such as the light-emitting element 62 and the light-emitting element 63) can be omitted. Similarly, when the inspection device 10 only performs inspection based on colorimetry, the structures related to the turbidimetric inspection (such as the light-emitting element 41 and the through-hole 51) can be omitted. Moreover, when performing colorimetric inspection only through a specific single wavelength (for example, purple light or blue light), the inspection device 10 can omit either the light-emitting element 62 and the related structures (such as the through-hole 72L and the through-hole 72R) or the light-emitting element 63 and the related structures (such as the through-hole 73L and the through-hole 73R).

[0087] In the first embodiment, the second embodiment, and the modified examples thereof, the light-emitting element 62 and the light-emitting element 63 are preferably arranged at the midpoint between the two light-emitting elements 41. This is to enable light to be incident optically symmetrically with respect to two adjacent test specimens 21. If light is incident optically symmetrically with respect to two adjacent test specimens 21, the inspection accuracy can be improved. This is particularly effective when performing calculations in the determination of the presence or absence of endotoxin, etc.

[0088] In the first embodiment, the second embodiment, and the modified examples thereof, the inspection device 10 performs endotoxin inspection, but the present invention can be applied to devices for performing inspections other than endotoxin inspection, such as detecting transmitted light or scattered light.

[0089] In the first embodiment, the second embodiment, and the modified examples thereof, the inspection device 10 includes one measurement unit 15, but the inspection device 10 can include a plurality of measurement units 15 in the device main body 11. That is, the inspection device 10 can be configured to include a plurality of measurement units 15, and the measurement unit 15 includes: a test specimen 21 having a circular cross-section for accommodating the inspection object 13; a test specimen holding portion 22 for holding a plurality of test specimens 21 in a row; light-emitting elements 62, 63 for irradiating light to two adjacent test specimens 21 among the plurality of test specimens 21; a first light guide path 46 for guiding the light emitted by the light-emitting element; and a second light guide path 47 having a diameter smaller than that of the first light guide path 46 for guiding the light emitted by the light-emitting elements 62, 63 from the first light guide path 46 to the test specimen 21.

[0090] Symbol Description

[0091] 10 - Inspection device, 11 - Device main body, 12 - Computer, 13 - Object to be inspected, 15 - Measuring unit, 21 - Test body, 22 - Test body holding part, 23 - Light emitting part, 24 - Light guide part, 26 - Light detection part, 27 - Display part, 28 - Operation part, 31 - Opening, 32 - Heater, 41 - Light emitting element, 42 - Light, 46 - First light guide path, 47 - Second light guide path, 48 - Opening, 49 - Space, 51 - Through hole, 52 - Opening, 53 - Light receiving element, 54 - Opening, 62 - Light emitting element, 63 - Light emitting element, 72L - Through hole, 72R - Through hole, 73L - Through hole, 73R - Through hole, 81 - Shielding member, 82 - Opening, 86 - Spot, 87 - Spot, 88 - Spot, 91 - Color filter, 92 - Color filter, 93 - Color filter, 201 - Partition member, 202 - Opening, 203 - First through hole plate, 204 - Second through hole plate, 211 - First through hole, 212 - Second through hole, 213 - Third through hole, 221 - First through hole, 222 - Second through hole, 223 - Third through hole, 261 - Third through hole plate, 271 - First through hole, 272 - Second through hole, 273 - Third through hole.

Claims

1. An inspection device, comprising: A test body with a circular cross-section, which accommodates an object to be inspected; A test body holding part that holds a plurality of the test bodies in a row; A light-emitting element that irradiates light onto two adjacent ones of the plurality of test bodies held by the test body holding part; A first light guide path that guides the light emitted by the light-emitting element; and A second light guide path, which is formed to be thinner than the first light guide path, and guides the light emitted by the light-emitting element from the first light guide path to the test body, As the light-emitting element, it includes a first color light-emitting element that emits light of a first color and a second color light-emitting element that emits light of a second color different from the first color. In the arrangement of the light-emitting elements, the first color light-emitting element and the second color light-emitting element are alternately arranged.

2. The inspection device according to claim 1, wherein, The first light guide path is commonly provided for a plurality of the light-emitting elements.

3. The inspection device according to claim 1 or 2, wherein, The second light guide path has a through hole parallel to the direction connecting the light-emitting element and the test body.

4. The inspection device according to claim 1 or 2, wherein, The second light guide path is a structure in which a plurality of plates having through holes are arranged so that light passes through the light-emitting element and the test body.

5. The inspection device according to claim 1 or 2, wherein, Each of the test bodies is provided with a light-receiving element that receives the light transmitted or scattered by the test body.

6. The inspection device according to claim 5, wherein, The light-emitting element irradiates light from an inclined direction with respect to the direction connecting the light-receiving element and the test body and orthogonal to the arrangement direction of the test bodies in the test body holding part.

7. The inspection device according to claim 5, wherein, The light-receiving element has a shielding member that restricts the incidence of light, and receives the light transmitted or scattered by the test body through an opening provided in the shielding member.

8. The inspection device according to claim 7, wherein, The opening is in a shape that is longer in the arrangement direction of the plurality of light-emitting elements.

9. The inspection device according to claim 7, wherein, The opening is provided with a color filter that selectively transmits the light emitted by the light-emitting element.

10. The inspection device according to claim 9, wherein, The opening is divided into a plurality of regions, and each region is provided with a color filter that transmits light of a different color.

11. The inspection device according to claim 5, wherein, In addition to the light-emitting element, a third color light-emitting element is further provided between the first color light-emitting element and the second color light-emitting element. The third color light-emitting element emits light of a third color different from the first color and the second color, and irradiates light from the direction connecting the light-receiving element and the test body and orthogonal to the arrangement direction of the test bodies in the test body holding part.

12. An inspection device includes a plurality of measurement units, each of the measurement units having: a test body with a circular cross-section that houses an object to be inspected; a test body holding portion that holds the plurality of test bodies in a row; a light-emitting element that emits light to two adjacent ones of the plurality of test bodies; a first light guide path that guides the light emitted by the light-emitting element; and a second light guide path that is formed to have a diameter smaller than that of the first light guide path and guides the light emitted by the light-emitting element from the first light guide path to the test body. As the light-emitting element, a first color light-emitting element that emits light of a first color and a second color light-emitting element that emits light of a second color different from the first color are provided, and in the arrangement of the light-emitting elements, the first color light-emitting element and the second color light-emitting element are alternately arranged.

Images