JPWO2018135233A1 - Foreign matter inspection device, foreign matter inspection method, and manufacturing device - Google Patents

Abstract

The foreign matter inspection method is a foreign matter inspection method for determining whether or not foreign matter is mixed in an object, and prepares a standard sample (20) having no foreign matter and having a thickness smaller than that of the object. And detecting the light from the light source (6) through the standard sample (20) and arriving at the detection unit (7) without passing through the object. Acquiring data of the spectrum of the reflected light as reference data (11), and causing at least a part of the light from the light source (6) to pass through the object at least once and reach the detection unit (7). Detecting the data of the spectrum of the light received by the detection unit (7) as measurement data; and determining whether or not a foreign object has entered the object based on the measurement data and the reference data. And a step.

Description

  The present invention relates to a foreign substance inspection device and a foreign substance inspection method. This application claims the priority based on Japanese Patent Application No. 2017-005840 filed on January 17, 2017. The entire contents described in the Japanese patent application are incorporated herein by reference. In particular, the present invention relates to a foreign substance inspection method and a foreign substance inspection apparatus which are suitable for non-destructively determining the presence or absence of a foreign substance mixed into an object, for example, the presence or absence of an organic foreign substance such as hair or insects. Furthermore, the invention also relates to a manufacturing device.

  Increasing consumer awareness of safety has led to a closer look at the incorporation of foreign matter into products. For example, with the aging, the number of rapidly disintegrating orally disintegrating tablets and chewable tablets is increasing, but foreign matter found inside was found that was not found in the era when there were many products to be swallowed. Are likely to occur.

  When foreign matter is introduced, it gives consumers anxiety and stress, and tends to avoid purchasing products of manufacturers whose reliability has been impaired. Further, when foreign matter is mixed, enormous loss occurs because the recovery procedure stipulated by law is taken.

  In such a foreign matter mixing problem, organic substances such as hair and insects are overwhelmingly large as foreign substances to be found. Nevertheless, in most cases, foreign matter inspection devices introduced into production lines are intended to detect external foreign matter that can be detected by visual inspection and inorganic substances that are easily found by X-rays or magnetic force. . In the case where a foreign substance made of an organic substance was mixed in the object, it could not be detected only by the appearance inspection, and could not be detected by the inspection using X-rays or magnetic force. Therefore, the only way to do this is to carry out a sampling inspection of the object or rely on hygiene control to prevent it from occurring.

  For pharmaceuticals, there is an example of analyzing foreign substances inside by X-ray computed tomography (X-ray CT: Computed Tomography). However, it is only used as research equipment for laboratories. There is no inline technology for non-destructive, non-destructive detection of organic matter inside objects.

  On the other hand, several methods have been studied to detect contamination of foods with foreign substances composed of organic substances. For example, JP-A-2012-189390 (Patent Document 1) is cited.

  In Patent Literature 1, based on hyperspectral images, a standard is used for foods and medicines such as beans dispersedly mounted on a belt conveyor by using reflected, transmitted, and scattered light of 1940 nm to 2400 nm with clear hair peaks. The relative intensity to the spectrum is determined and analyzed using statistical means to detect hair.

JP 2012-189390 A

  The technique described in Patent Literature 1 cannot be applied to an inspection object in which light scattering or absorption is larger than that of foods and medicines placed in a dispersed manner. For example, a tablet formed into a solid by compressing a powder has a large scattering of light inside, and a material such as starch used absorbs too much light in this wavelength range. If is applied as it is, the feature relating to the foreign matter that should appear on the spectrum is masked and cannot be detected. In Patent Document 1, although light absorption by hair is observed, even if foreign matter other than hair, such as an insect, is mixed in, it cannot be detected.

  Therefore, an object of the present invention is to provide a foreign substance inspection apparatus and a foreign substance inspection method capable of non-destructively determining the presence or absence of a foreign substance mixed inside an object. Another object of the present invention is to provide a manufacturing apparatus capable of improving the yield by utilizing such determination.

  In order to achieve the above object, a foreign matter inspection method according to the present invention is a foreign matter inspection method for determining whether or not foreign matter is mixed in an object, and is thinner than the object without foreign matter mixed therein. A step of preparing a standard sample having a thickness, and light from a light source is transmitted through the standard sample, and reaches the detection unit without passing through the object, and the light detected by the detection unit Acquiring the spectrum data as reference data, so that at least part of the light from the light source passes through the object at least once without passing through the standard sample and reaches the detection unit. Detecting the spectrum data of the light received by the detection unit as measurement data, and determining whether or not a foreign object has entered the target object based on the measurement data and the reference data. And a that process.

  ADVANTAGE OF THE INVENTION According to this invention, the presence or absence of the foreign material mixed in the inside of an object can be determined nondestructively.

4 is a flowchart of a foreign substance inspection method according to the first embodiment based on the present invention. FIG. 3 is a cross-sectional view of an example of an object handled by the foreign matter inspection method according to the first embodiment of the present invention. FIG. 3 is a cross-sectional view of an example of a standard sample handled by the foreign matter inspection method according to the first embodiment of the present invention. FIG. 5 is an explanatory diagram showing a state where a step S1 of the foreign matter inspection method according to the first embodiment of the present invention is being performed. FIG. 4 is an explanatory diagram showing a state where a step S2 of the foreign substance inspection method according to the first embodiment of the present invention is being performed. FIG. 4 is a perspective view of the vicinity of a light-transmitting portion of a holding portion that can be used in the foreign matter inspection method according to the first embodiment of the present invention. FIG. 9 is a cross-sectional view of the vicinity of the holding unit in a state where an object is placed on the holding unit of the first modification of the foreign matter inspection device according to the first embodiment of the present invention. FIG. 5 is a plan view of the vicinity of a holding unit of a first modification of the foreign substance inspection device according to the first embodiment of the present invention. FIG. 9 is a cross-sectional view of the vicinity of the holding unit in a state where an object is placed on the holding unit of the second modification of the foreign matter inspection device according to the first embodiment of the present invention. FIG. 11 is an explanatory diagram of an example in which two indices are calculated and determined by plotting on a graph. FIG. 9 is a conceptual diagram of a foreign substance inspection device according to a second embodiment of the present invention. FIG. 13 is a conceptual diagram of a foreign substance inspection device according to a third embodiment of the present invention. FIG. 15 is a conceptual diagram of a manufacturing apparatus according to a fourth embodiment based on the present invention.

(Embodiment 1)
With reference to FIGS. 1 to 10, a foreign matter inspection method according to the first embodiment of the present invention will be described. FIG. 1 shows a flowchart of the foreign substance inspection method according to the present embodiment. This foreign matter inspection method is a foreign matter inspection method for determining whether or not foreign matter is mixed in an object, and includes a step S0 of preparing a standard sample having no foreign matter and having a thickness smaller than that of the object. And the light from the light source transmits through the standard sample, and reaches the detection unit without transmitting through the object, and acquires data of the spectrum of the light detected by the detection unit as reference data. Step S1 and at least a part of the light from the light source is transmitted through the object at least once without reaching the standard sample and reaches the detection unit, and is received by the detection unit. The method includes a step S2 of detecting data of a light spectrum as measurement data, and a step S3 of determining whether or not a foreign substance has entered the object based on the measurement data and the reference data.

  In this foreign matter inspection method, it is determined whether or not foreign matter is mixed in the object 1. An example of the object 1 is shown in FIG. As the standard sample 20 prepared in the step S0, a standard sample corresponding to each object 1 is prepared. An example of the standard sample 20 corresponding to the object 1 is shown in FIG. Assuming that the average thickness of the object 1 is T1, the thickness of the standard sample 20 is T2, and T2 is clearly smaller than T1. When there are a plurality of objects 1, it is considered that the thickness varies due to a manufacturing error or the like. However, the thickness T <b> 2 of the standard sample 20 may be generated in consideration of the thickness variation of the object 1. Make sure that the thickness is smaller than the minimum value. For example, thickness T2 may be 90% or 80% of thickness T1. For example, the thickness T2 may be 2/3 of the thickness T1. Since the object 1 is to be inspected from now on, it is unknown whether or not foreign matter has entered the inside, but the standard sample 20 is a sample in which it is known in advance that no foreign matter has entered the inside. is there. It can be confirmed by a known technique such as optical CT (Computed Tomography) that no foreign matter is mixed in the inside. In step S0, a standard sample 20 satisfying the above conditions is prepared.

  Since the foreign substance inspection method in the present embodiment is preferably performed by a foreign substance inspection apparatus having a certain configuration, the configuration of the foreign substance inspection apparatus will also be described below. FIGS. 4 and 5 show examples of using the foreign matter inspection apparatus. It should be noted that the use of such a foreign substance inspection apparatus is not essential in performing the foreign substance inspection method in the present embodiment.

  The foreign matter inspection apparatus 101 holds a light source 6 for irradiating light to the object 1, a detection unit 7 for detecting light emitted from the light source 6 and transmitted through the object 1, and reference data 11. And a determination unit 10 that determines whether or not a foreign object is included in the target object 1 based on the data of the light detected by the detection unit 7 and the reference data 11. A first state in which the light from the light source 6 passes through the standard sample 20 having a thickness smaller than that of the target object 1 with no foreign matter and reaching the detection unit 7 at least once, and a light from the light source 6. Can be switched between a second state in which the light passes through the target unit 1 at least once and reaches the detection unit 7, and the reference data 11 is data obtained by the detection unit 7 in the first state. . Further, the foreign substance inspection device 101 includes a holding unit 5 for holding the target object 1.

  Step S1 can be performed with the foreign substance inspection apparatus 101 in the first state. FIG. 4 shows a state where the process S1 is performed by the foreign substance inspection apparatus 101. The holding unit 5 holds not the object 1 but the standard sample 20. The light emitted from the light source 6 passes not through the object 1 but through the standard sample 20 and reaches the detection unit 7. The light may pass through a certain light collecting part between the standard sample 20 and the detecting part 7. The light collector may be, for example, a lens. The condensing unit may be a lens 5d as shown in FIG. In this example, the lens 5d is provided inside the hole 5a as a part of the holding unit 5. The light collecting unit is not limited to a part of the holding unit 5 and may be provided separately from the holding unit 5. In FIG. 4, the standard sample 20 is also shown for convenience of description, but the standard sample 20 itself is not a part of the foreign substance inspection device 101.

  Step S2 can be performed with the foreign substance inspection apparatus 101 in the second state. FIG. 5 shows a state where the process S2 is performed by the foreign substance inspection device 101. The target 1 is held in the holding unit 5. Light emitted from the light source 6 passes through the object 1 and reaches the detection unit 7. In FIG. 5, the object 1 is also displayed for convenience of description, but the object 1 itself is not a part of the foreign matter inspection apparatus 101.

(Object)
The object 1 may be, for example, a tablet. The object 1 may have a flat shape. The object 1 may be a solid formed by solidifying a powder. The object 1 may be a medicine or a food. The target object 1 may be a capsule in which some contents are contained. The capsule referred to here may be a soft capsule.

  Organic substances such as hair and insects are assumed to be detected as foreign substances by the inspection. Resin pieces and the like may also be included in those to be detected as foreign substances.

(light source)
The light source 6 may include a halogen lamp. The wavelength of the light may be, for example, not less than 600 nm and not more than 2500 nm. The wavelength of the light to be irradiated is not limited to this range. However, in this wavelength range, the light is easily transmitted through the object 1, and the object 1 is not damaged as in the case of irradiating ultraviolet rays. ,preferable. Further, the wavelength of the light may be, for example, not less than 800 nm and not more than 1600 nm. The wavelength of the light to be irradiated is not limited to this range, but there are large absorption peaks such as starch, lactose, and crystalline cellulose, which are often contained in general tablets, near the light wavelength of 1600 nm. The effect on the spectrum due to is masked. On the other hand, if the wavelength is too short or too long, light loss due to light scattering, absorption, etc. will increase. Therefore, in this embodiment mode, the wavelength of light to be applied is preferably 800 nm or more and 1600 nm or less. In the present embodiment, a halogen lamp is described as an example of the light source 6, but the type of the light source is not limited to this, and another type of lamp may be used. The light source 6 may be any device that can emit light having a wavelength capable of detecting a foreign substance, and may be, for example, any of a tungsten lamp, a phosphor, an LED, and a laser.

  The number of light sources 6, the wavelength of light, the intensity of light, and the like are appropriately selected according to the configuration of the apparatus, the type of the object 1, and the like. In the present embodiment, the object 1 is irradiated with light from one direction using one light source 6, but is not limited to this, and the light is irradiated simultaneously from different directions using two or more light sources. You may.

  The light adjusting unit 12 may be arranged below the light source 6 corresponding to the light source 6. The light adjustment unit 12 includes, for example, a lens.

(Light adjustment unit)
The light adjusting unit 12 adjusts the traveling direction of light from the light source 6. As described above, the light adjustment unit 12 includes, for example, a lens. Irradiation light is applied so as to collectively cover the entirety of the object 1 so that foreign matter mixed into the end of the object 1 can be detected. The light adjusting unit 12 is focused so that such irradiation can be performed. However, if the irradiation area of the light is too large than the object 1, a wasteful portion of the irradiated light becomes large. Therefore, the irradiation area is set to be slightly larger than the projection area of the object 1. The area of the irradiation area may be, for example, 100.1% of the projection area of the object 1. Here, the “projected area of the object 1” is an area obtained by projecting the object 1 on a virtual plane perpendicular to the light irradiation direction.

  For example, when the target object 1 is a tablet manufactured by a tableting method, it is preferable to irradiate light along a direction pressed by a mortar and a punch at the time of manufacturing the tablet. In general, in a tableting method in which a tablet and a punch are used to form a tablet, the outer peripheral surface of the tablet is hard and light is difficult to transmit. Therefore, by irradiating light so as to be incident from other than the outer peripheral surface, light transmission can be made easier. The direction of light irradiation is not limited to this, and irradiation may be performed from an appropriate direction according to the inspection status of foreign matter.

  When the light adjustment unit 12 includes a lens, the lens preferably has a certain degree of heat resistance.

  The light adjusting section may guide the light emitted from the light source body to a desired position by a light guide made of, for example, an optical fiber. The light adjusting section may have a form in which a lens is arranged at the tip of such a light guide. In this case, light loss may occur inside the light guide means, but there is an advantage that light irradiation can be easily performed from a position close to the object.

  In addition, the light adjustment unit 12 may include a shutter that blocks light. When the shutter is provided as described above, the shutter should be closed in accordance with the transport of the object so as to block the light so that the light from the object 1 that has been measured enters the detection unit 7 and does not become noise. Can be. In addition, when the shutter is provided in this way, even when it is desired to temporarily stop the light irradiation for performing a work such as exchanging a sample or the like, by closing the shutter, the external light can be kept while the light source is kept on. Can realize a state in which no light is radiated, and the desired work can be continued, so that the time required for starting up the light source can be saved. When the light source is, for example, a halogen lamp, the time required for starting up the halogen lamp can be saved, which is effective.

(Holding part)
The holding part 5 has a hole 5a. In the example shown here, the hole 5a is a light transmitting part. FIG. 6 is a perspective view of the vicinity of the hole 5a of the holding unit 5. The hole 5a is larger than the outer shape of the object 1. When the object 1 is circular, the inner diameter of the hole 5 a is larger than the outer diameter of the object 1. This difference in diameter may be small. As shown in FIGS. 4 and 5, the holding section 5 includes a first portion 5b, a second portion 5c, and a lens 5d. The first portion 5b is formed of a material that does not transmit light. The second portion 5c is formed of a material that transmits light. 4 and 5, the first portion 5b exists not only above but also below the second portion 5c. As shown in FIGS. 4 and 5, the second portion 5c may be sandwiched from above and below by the first portion 5b. The second portion 5c has an opening 5c1. The diameter of the opening 5c1 is smaller than the outer diameter of the object 1. The lens 5d is disposed inside the hole 5a below the second portion 5c. The lens 5d is for collecting the transmitted light toward the detection unit 7.

  The object 1 can be supported by the second portion 5c inside the hole 5a. The first portion 5b has low transmittance to near-infrared light so that stray light from the outside does not enter. The first portion 5b can be realized by forming a member using a low-permeability material such as black alumite. Alternatively, the first portion 5b can be realized by forming a member with another material and then coating with a material having low permeability such as black alumite.

  In the example shown here, the holding unit 5 has the hole 5a, and holds the object 1 by arranging it inside the hole 5a, but this is only an example. The hole is not limited to a hole as long as the object 1 can be held and the passage of the transmitted light can be secured to a sufficient extent for measuring the transmitted light.

  In the example shown here, the second portion 5c is provided to support the object 1, and the second portion 5c has the opening 5c1, but in order not to block transmitted light as much as possible. The area of the opening 5c1 may be, for example, 90% of the surface area of the surface where the object 1 contacts the second portion 5c. This ratio is not limited to 90%, and may be, for example, 95%.

  In the example shown here, the second portion 5c has a plate shape and may be called a "support plate". Here, an example is shown in which the second portion 5c has transparency with respect to the wavelength of transmitted light. In this case, the second portion 5c may be formed using a transparent member having a wavelength characteristic of transmitting light. As a material of the second portion 5c, for example, quartz glass or synthetic quartz glass can be adopted. When the second portion 5c has transparency, light transmitted through the object can be used efficiently.

  The second portion 5c is not limited to being transparent to the wavelength of the transmitted light. The second portion 5c may have a translucent configuration or an opaque configuration. When the second portion 5c is not made to have a light-transmitting property, the range of material selection is widened, so that a material that can easily hold the object can be selected. Further, depending on the shape of the target object, the ratio of noise light passing through the gap between the target object 1 and the holding unit 5 may increase, but if the second portion 5c is opaque, such noise light is reduced. Can be shut off.

(Detection unit)
The light transmitted through the object 1 held by the holding unit 5 enters the detection unit 7. The light transmitted through the object 1 may pass through some light collecting unit before entering the detection unit 7. The light collector may be, for example, a lens 5d provided as a part of the holder 5, or may be provided separately from the holder 5. The light collector may include some kind of lens, or may include some kind of reflector. Light from the holding unit 5 to the detection unit 7 may be guided by a light guide made of an optical fiber.

  A shutter for blocking light may be arranged at the entrance of the detection unit 7 so as to be openable and closable. By doing so, the shutter can be closed and the light can be blocked so that the light from the measured object has not entered the detection unit 7 and becomes noise. In addition, arranging the shutter in this manner is advantageous in that the light can be blocked when it is desired to temporarily prevent strong light from entering the detection unit 7.

  For example, a polychromator-type spectroscope may be used as the detection unit 7. In a polychromator-type spectroscope, a large number of light receiving elements are arranged in front of a prism that splits light into each wavelength, and light of each wavelength can be measured simultaneously. A polychromator-type spectrometer is also called a multi-channel detector. Polychromator-type spectrometers have the advantage that the measurement time is fast.

  The polychromator includes a type using a light receiving element and a prism, and a type using a CCD. The type of polychromator is appropriately selected according to the configuration of the inspection device, the type of tablet to be measured, the wavelength of light, and the like. In the present embodiment, as an example, a method in which an InGaAs light receiving element and a prism that are more accurate than a CCD are combined is used.

  The spectroscope provided in the detection unit 7 measures the spectrum of the received light. The detection unit 7 does not always include a spectroscope. The detection unit 7 may be configured to include, for example, one of a photodiode, a phototransistor, an avalanche photodiode, and a photomultiplier tube. The number, arrangement, and the like of the light receiving elements in the detection unit 7 are appropriately selected according to the configuration of the foreign substance inspection device, the type of the object to be measured, the wavelength of light used, and the like.

(Control unit)
As shown in FIGS. 4 and 5, the foreign matter inspection device 101 may include a control unit 13. The control unit 13 controls the light source 6, the storage unit 9, the detection unit 7, the transport unit, and the like. When the light adjustment unit 12 or the detection unit 7 has a shutter, the control unit 13 may be configured to control the opening and closing of the shutter. Each process by the control unit 13 may be realized by a central processing unit (CPU: Central Processing Unit).

(Judgment unit)
The determination unit 10 performs an operation with reference to the measurement data of the object 1 obtained by the detection unit 7 based on the transmitted light and the data stored in the storage unit 9, and the foreign matter mixed into the object 1 Is determined. In the example shown here, the determination unit 10 is shown as being different from the control unit 13, but the determination unit 10 may be provided as a part of the control unit. The control unit may also serve as the determination unit.

(Storage unit)
The storage unit 9 is for storing information necessary for the inspection. The storage unit 9 includes, for example, an area for temporarily storing measurement data obtained by the detection unit 7, various programs executed by the control unit, an area for storing data used in these programs, and a program for storing these programs. It has an area to be loaded and a work area used when these programs are executed. The various programs referred to here are, for example, a program for making a determination, a calculation algorithm, a database, and the like. The storage unit 9 can hold reference data 11 used for determination by the determination unit 10.

(Work flow in the foreign material inspection method)
The work flow when performing the inspection based on the foreign substance inspection method according to the present embodiment will be described more specifically. Here, the description will be made assuming that the inspection is performed using the foreign substance inspection apparatus 101, but the same concept can be applied to the case where the inspection is performed using another apparatus.

  Before performing the inspection, the lens of the light adjustment unit 12 is focused beforehand so that the irradiation light covers the object 1 when the object 1 is in the holding unit 5. That is, the focus is set so that the irradiation light covers at least 100% of the cross-sectional area of the object 1 in a plane perpendicular to the irradiation light. However, if the light irradiation area is too large compared to the target 1, the waste area of the entire light increases, so the irradiation area is slightly larger than the target 1. Here, it is 100.1% of the total cross-sectional area.

  Measurement conditions that can be changed artificially, such as light irradiation time, irradiation light amount, slit width of the spectrometer, integration time, average number, set temperature, sensitivity, etc., are predetermined in accordance with the type of the target object 1 and are determined in advance. In the meantime, these conditions shall not be changed.

  One object 1 is held in the holding unit 5 located at the measurement position, and light is emitted to each object 1 for a certain period of time. The light irradiation time is set to be short enough to avoid inappropriate heating of the object 1. In this embodiment mode, the irradiation time is set to 0.8 seconds each time.

  By irradiating the light to each of the plurality of holding units 5 individually instead of simultaneously, it is possible to prevent stray light from another holding unit 5. The light source 6 may be any light source that can irradiate light for a short time. In addition to electric control, for example, a flash-type lamp or a chopper may be used.

  In the present embodiment, the irradiation is performed for a short time of 0.8 seconds per one object 1, but the irradiation time is not limited to this. Increasing the amount of light makes it easier for light to pass through the target 1, so that the irradiation time may be longer depending on the type of the target 1. However, since the irradiation light includes a heat ray, the object 1 is heated when the light is irradiated. The temperature increases as the amount of light to be irradiated increases and as the irradiation time increases. Depending on the type of the object 1, the components may be deteriorated due to excessive heating. When the temperature of the object 1 has already been increased by heating in a drying step or the like before the inspection step, the temperature is set as the upper limit. This is because the temperature in the drying step or the like that is performed before is generally maintained at a temperature lower than the temperature at which the components of the object 1 deteriorate. That is, the degree of temperature rise determined by the irradiation time and the amount of light to be irradiated is set to be equal to or lower than the temperature generated in some process performed before the inspection process, and the irradiation light amount is increased as much as possible within a range satisfying this condition. Is preferably shortened. The irradiation time and the upper limit of the irradiation light amount are appropriately determined depending on the components and the structure of the object 1.

  Note that it is not sufficient to transport the object 1 in a direction perpendicular to the light irradiation direction, and a mechanism for holding or fixing the object 1 so that the object 1 does not move during transportation is used. Preferably.

  Various modifications are conceivable for the foreign matter inspection device according to the first embodiment based on the present invention. As a first modification, the holding unit 5 may have a configuration shown in FIGS. 7 and 8, for example. In this modified example, the holding portion 5 has a hole 5a and includes a protrusion 5e protruding toward the inside of the hole 5a. FIG. 7 is a cross-sectional view illustrating a state where the target object 1 is placed on the holding unit 5, and FIG. 8 is a plan view illustrating the vicinity of the holding unit 5 without the target object 1. In this example, three projections 5e are provided at regular intervals of about 120 °. The number of protrusions 5e may be other than three. The arrangement angles of the projections 5e need not be equal.

  As a second modification, for example, a configuration as shown in FIG. 9 may be used. In this example, the holding section 5 includes a first portion 5b, a second portion 5c, and a lens 5d, and the second portion 5c has an opening. The opening of the second portion 5c has a mortar shape. The opening of the second portion 5c is preferably in a mortar shape so that the shape of the object 1 fits.

  First, before inspecting the object 1, a measurement for acquiring the reference data 11 is performed. The measurement for acquiring the reference data 11 needs to be performed at least once before the inspection of the object 1 is started. This measurement is performed with the foreign substance inspection apparatus 101 in the first state. That is, the standard sample 20 is placed on the holding unit 5 instead of the target object 1 and irradiated with light.

  It should be noted that when time has elapsed since the previous acquisition of the reference data 11 or when the type of the object to be inspected is changed, whether or not to repeat the measurement for acquiring the reference data 11 is determined according to the exact inspection required by the user. It is appropriately selected according to the configuration of the inspection apparatus, the type of the object to be measured, the wavelength of light, and the like. In the present embodiment, if the types of objects to be inspected are the same, the measurement for acquiring the reference data 11 is performed, for example, in one day before the start of the inspection in the morning and before the start of the inspection in the afternoon. It is only necessary to carry out each time. The ND filter used at this time uses a filter determined according to the type of the object. Normally, if the type of the target object changes, what should be prepared as a standard sample also changes, so that it is necessary to perform step S0.

(Step 1 Measurement of reference data)
This is a measurement performed with the foreign substance inspection device 101 in the first state.
1. A standard sample 20 corresponding to the object 1 is prepared.
2. The holding unit 5 on which the standard sample 20 is installed instead of the object 1 is arranged in the light irradiation area.
3. Turn on the light source. As a result, light from the light source 6 enters the light adjustment unit 12. In the light adjusting section 12, some adjustment is made to the light as needed. The adjustment is, for example, correction of an optical path.
4. Light from the light adjusting unit 12 passes through the inside of the standard sample 20. The “transmission” here includes passing through the standard sample 20 while scattering (including multiple scattering). Thereafter, the light is condensed by the lens 5d and enters the detection unit 7. A light spectrum (light intensity for each wavelength) is measured by a spectroscope provided in the detection unit 7 and stored in the storage unit 9 as reference data 11. The light intensity in the reference data is defined as I0.

(2nd stage Measurement of object)
This is a measurement performed with the foreign substance inspection apparatus 101 in the second state.
5. The inspection of the object 1 is started. With the object 1 placed on the holding unit 5, the holding unit 5 is arranged in the light irradiation area. At this time, the position of the holding unit 5 may be the same as the position when the measurement of the reference data is performed.
6. The object 1 is irradiated with light.
7. Light passes through the inside of the object 1. Here, the “transmission” includes passing through the target object 1 while scattering (including multiple scattering) inside the target object 1.
8. The light transmitted through the object 1 is condensed by the lens 5 d and enters the detection unit 7.
9. The intensity I of light for each wavelength is measured by a spectroscope provided in the detection unit 7. The measurement result is stored in the storage unit 9 as measurement data. The transmitted light includes information inside the object 1.

(Third stage Determination of presence or absence of foreign matter)
10. Using the measured light intensity, the determination unit 10 performs conversion for extracting information on the foreign substance from the difference between the incident light and the transmitted light. In the present embodiment, the absorbance for each wavelength is calculated with the absorbance A1 = log (I0 / I). When the target object 1 is a tablet, A1 cannot be strictly called an absorbance because light scattering inside is large, but here, this A1 is defined as an absorbance for convenience.
11. The determination unit 10 determines the presence or absence of foreign matter from the calculated absorbance A1.

  In the present embodiment, discriminant analysis is used. Specifically, a calculation model for calculating the predicted class value and the similarity of the sample from the absorbance is used. Methods for deriving a calculation model include a support vector machine, pattern recognition, analysis by Mahalanobis distance, SIMC (Soft Independent Modeling of Class Analysis) discriminant analysis, and canonical discriminant analysis. What is necessary is just to select an optimal derivation method and determine a calculation model according to the purpose of what kind of object and what to determine.

  Here, a calculation model for calculating the characteristics of a foreign substance included in a tablet as a target object is derived by a PLS-DA (Partial Linear Square-Discriminant Analysis) method, and a value calculated from measurement data of the tablet using this calculation model is: It is determined whether or not a foreign substance has entered based on whether or not the value is equal to or greater than a preset reference value. The calculation model for performing the calculation is determined by the wavelength of the irradiated light, the type of tablet, the configuration of the transport unit of the inspection device, and the like, and is stored in the storage unit 9 in advance.

  The determination unit 10 refers to the absorbance obtained from the measurement result of the detection unit 7 and the calculation model for each tablet type read from the database stored in the storage unit 9 to calculate an index indicating the characteristics of the tablet. Then, the presence or absence of foreign matter is determined.

  The determination unit 10 can perform determination using a relational database or a correspondence table, or determination using a graph plot or the like as appropriate according to the type of tablet.

  In the present embodiment, as shown in Table 1, a calculation model for calculating a predicted value and a bias value is used as an index for determining whether a tablet is a normal tablet or a tablet with mixed hair. If the predicted value calculated from the calculation model is 0.5 or more and the bias value is less than 0.5, “normal” is obtained. If the predicted value is less than 0.5 and the bias value is less than 0.5, “hair is mixed. Yes ". If the predicted value is less than 0.5 and the bias value is 0.5 or more, it cannot be specified that the hair is mixed, but insects are mixed inside or some abnormality such as cracks occurs. Are likely to be In this case, the type of abnormality can be specified using another calculation model. For example, by calculating an index of whether a tablet is a normal tablet or a tablet containing insects, the presence or absence of the insects can be detected.

  Depending on the type of tablet, as shown in FIG. 10, a plurality of indices can be calculated, plotted on a graph, and determined based on the area. In FIG. 10, a judgment value A and a judgment value B are calculated using two indices, respectively, and plotted using these. If it is above a predetermined reference straight line as plotted with a black circle, it can be determined that it is normal, and if it is below the reference straight line as plotted with a white circle, it can be determined that it is abnormal. In the example shown, a two-dimensional plot is performed, but the present invention is not limited to the two-dimensional plot. For example, three-dimensional plotting may be performed using three indices, and the inclusion of a foreign substance may be determined based on whether a normal tablet is plotted in an area where plotting is confirmed in advance.

  Whether to use only one index to judge only with numerical values as shown in Table 1 or to use multiple indices to judge with a plot as shown in FIG. 10 depends on the type of tablet and how strictly the user performs the inspection. May be determined as appropriate. Also, the reference values shown in Table 1 and the reference straight line shown in FIG. 10 may be appropriately determined in the same manner.

(When foreign matter is detected)
12. The object 1 determined to be contaminated with foreign matter or a lot including the object 1 is discarded. In the determination of foreign matter, there may be a situation where the cause of the abnormality cannot be identified although the abnormality is found. Even in such a case, it is desirable to discard the object 1 or a lot including the object. For example, there may be a case where it is found that there is an abnormality, but it is not clear whether it is hair contamination, insect contamination or other. In the present embodiment, even when an inorganic foreign substance is mixed even if no organic foreign substance is mixed, or when an abnormality such as a crack occurs inside without the foreign substance mixed, it is not normal. As a result, detection may be possible.

  According to the present embodiment, it is possible to non-destructively determine the presence / absence of a foreign substance mixed inside the object 1. In the present embodiment, since the sample having a thickness smaller than that of the object 1 is used as the standard sample, the amount of light transmitted through the object is reliably smaller than the amount of light transmitted through the standard sample. . Therefore, when the absorbance is calculated by the determination unit 10, the absorbance does not become a negative value but always becomes a positive value.

  In particular, when the object 1 is a tablet and is manufactured by compression molding using a tableting machine, the degree of pressurization varies, and the difference between the density and the thickness of each manufactured tablet is different. Tends to occur. In the case where the present embodiment is not applied, the absorbance may become almost zero or a negative value due to the manufacturing variation, and in such a situation, the accuracy of determining the presence or absence of a foreign substance deteriorates. It is thought to be done. However, according to the present embodiment, it is possible to ensure that the absorbance has a positive value even if there is manufacturing variation, so that it is possible to avoid deterioration in the accuracy of determining the presence or absence of foreign matter.

  In the foreign substance inspection method according to the present embodiment, it is preferable that the light emitted from light source 6 to target object 1 be irradiated so as to cover the entirety of target object 1. Irradiated light can be inspected to some extent even if it does not cover the entirety of the object 1, but it is preferable to cover the entirety in order to perform an accurate inspection.

  In the foreign substance inspection method according to the present embodiment, it is preferable that the wavelength of light emitted from light source 6 is not less than 600 nm and not more than 2500 nm. Furthermore, it is preferable that the wavelength of the light emitted from the light source 6 is 800 nm or more and 1600 nm or less. The reason is as described in the description of the light source.

  The foreign matter inspection device according to the present embodiment includes a holding unit 5 for holding the object 1, and the holding unit 5 includes a member having a light transmitting unit and the object disposed inside the light transmitting unit. A supporting portion extending at least partially over an inner region of the light-transmitting portion so as to support the object from below, in the second state, from the light source 6 toward the detecting portion 7 Preferably, the light passes through the light transmitting part. The “light-transmitting portion” here may be, for example, a hole 5a shown in FIGS. 4 to 6. The hole 5a is a through hole. However, the light transmitting portion is not limited to the through hole, but may be any portion through which light can pass. Therefore, the light transmitting portion may be, for example, a gap between some members. The translucent portion may be a portion where some translucent member is arranged. It may be a part that is partially or completely closed by any translucent member. The “support portion” here may be, for example, a portion in which the second portion 5c shown in FIGS. 4 to 6 projects inside the hole 5a. The support portion does not necessarily protrude over the entire circumference as described above, and may have one or more protrusions protruding inward. The support may be like the protrusion 5e shown in FIGS. 7 and 8.

  The support may be transparent. By employing this configuration, the degree of blocking of the transmitted light by the support portion can be reduced, and the inspection can be performed efficiently. In the example shown in FIGS. 4 to 6, the second portion 5c is transparent, but such a configuration may be used.

(Supplement)
If the wavelength dependence of the attenuation rate of the ND filter is known in advance, the standard data can be corrected based on the wavelength dependence, thereby making it possible to more accurately determine a foreign substance. Further, the appearance inspection may be additionally performed before or after performing the foreign matter inspection method according to the present invention. In this way, if the appearance inspection is further combined with the foreign matter inspection method according to the present embodiment, the foreign matter can be more reliably detected.

  Further, the storage unit 9 may record the inspection result and the inspection data such as the date and time and the temperature. For example, records on the status of other devices, such as data on the number and time of people entering and leaving a certain space, materials used, cleaning timing of tableting machines, and whether or not fluorescent lamps were damaged, etc. may be recorded. Good. If the data is analyzed in combination with these data, it can be presented as comprehensive data for preventing foreign matter from being mixed. In other words, it can be used as a means for preventing recurrence of foreign matter contamination.

(Embodiment 2)
Referring to FIG. 11, a foreign matter inspection apparatus according to the second embodiment of the present invention will be described.

  In the first embodiment, an example has been described in which light is applied to the object 1 from one direction using one light source 6. However, the present invention is not limited to this, and light is emitted from different directions using two or more light sources. Irradiation may be performed. In the foreign matter inspection apparatus 102 according to the present embodiment, as shown in FIG. 11, irradiation is performed from one side of the holding unit 5 toward the object 1 using the light sources 6a and 6b. On the other side of the holding unit 5, the light transmitted through the object 1 is guided to the detection unit 7 by the lens 5d. The configuration and usage of the other parts are the same as those described in the first embodiment. In FIG. 11, the determination unit 10, the control unit 13, and the like are not shown.

  The same effect as that described in the first embodiment can also be obtained by the foreign substance inspection device according to the present embodiment.

(Embodiment 3)
Referring to FIG. 12, a foreign substance inspection apparatus according to Embodiment 3 of the present invention will be described.

  In the first embodiment, the light transmitted through the object 1 is received by the detection unit 7, but the light is not limited to the transmitted light, but may be reflected light. In the foreign substance inspection device 103 according to the present embodiment, as shown in FIG. 12, the bottom surface of the concave portion of the holding unit 5 is formed as a surface that reflects light transmitted through the object 1. By irradiating the light from the light source 6 to the object 1, the light transmitted through the object 1 is reflected on the bottom surface of the concave portion of the holding unit 5 and transmitted through the object 1 again. In this manner, the light that has passed through the object 1 and has traveled away from the holding unit 5 is received by the detection unit 7. The foreign matter inspection apparatus according to the present embodiment includes a holding unit 5 for holding the object 1, the holding unit 5 has a reflecting surface, and at least a part of the light once transmitted through the object 1 is the reflecting surface. Then, the light is reflected and transmitted through the object 1 again, and then enters the detection unit 7. The configuration and usage of the other parts are the same as those described in the first embodiment. In FIG. 9, the determination unit 10, the control unit 13, and the like are not shown.

  The same effect as that described in the first embodiment can also be obtained by the foreign substance inspection device according to the present embodiment. In the present embodiment, the light reaches the detection unit 7 after transmitting through the inside of the object 1 twice, so that a more accurate inspection can be performed.

(Embodiment 4)
Referring to FIG. 13, a description will be given of a manufacturing apparatus according to the fourth embodiment of the present invention. The manufacturing apparatus according to the present embodiment is an apparatus for manufacturing the object 1, and includes a foreign matter inspection apparatus having any one of the configurations described above. This manufacturing apparatus is shown in FIG. 13 is conceptual only, and the layout of the manufacturing apparatus is not limited to this. The manufacturing apparatus 501 includes a manufacturing unit 301 for manufacturing the object 1, and further includes the foreign substance inspection apparatus 101. The object 1 produced by the production unit 301 is inspected by the foreign substance inspection device 101. The transport of the object 1 to the foreign matter inspection device 101 is performed by, for example, the transport device 302. The transport device 302 transports the object 1 stored in the cassette. The transport device 302 shown here is merely an example, and is not limited to such a configuration.

  According to the manufacturing apparatus in the present embodiment, only the object 1 determined to be free of foreign matter through inspection by the foreign matter inspection apparatus 101 is obtained as a product. Therefore, in this embodiment, an object can be efficiently manufactured. In particular, when foreign matter is mixed in the target object, it can be appropriately detected and excluded as a defective product, so that the yield can be improved.

  In the present embodiment, the manufacturing unit 301 and the foreign matter inspection device 101 are shown as devices housed in separate housings, respectively. However, this is merely an example conceptually, and both are integrated. And may be housed in a single housing.

  In each of the embodiments described above, a tablet, that is, a tablet is shown as the target object 1. However, the present invention is not limited to the tablet form, and can be applied to powders, granules, capsules, and films. The target object 1 may be, for example, a medicine, a medicine, a food, an ingestion for health maintenance, or the like. The object 1 may be any one selected from the group consisting of medicines, medicines, ingestibles for health maintenance, nutrients, granules, powders, films, and capsules.

  In the foreign substance inspection method according to each embodiment, the object 1 is manufactured by the tableting method, and the light from the light source 6 is applied in the same direction as the direction in which the object 1 is pressed during the manufacturing by the tableting method. Therefore, it is preferable to transmit the object 1. This is because the light transmittance is improved in this direction.

Note that a plurality of the above embodiments may be appropriately combined and adopted.
Note that the above-described embodiment disclosed this time is illustrative in all aspects and is not restrictive. The scope of the present invention is defined by the appended claims, and includes all modifications within the scope and meaning equivalent to the appended claims.

  DESCRIPTION OF SYMBOLS 1 Object, 5 holding | maintenance part, 5a hole, 5b 1st part, 5c 2nd part, 5c1 opening, 5d lens, 6 light sources, 7 detection part, 9 storage part, 10 judgment part, 11 reference data, 12 light adjustment Unit, 13 control unit, 20 standard samples, 101, 102, 103 Foreign substance inspection device.

Claims (10)

A foreign matter inspection method for determining whether a foreign matter is mixed in an object,
A step of preparing a standard sample having a thickness smaller than that of the target object without foreign matter mixed therein,
A step in which light from a light source transmits through the standard sample, and reaches the detection unit without transmitting through the object, and acquires data of spectrum of light detected by the detection unit as reference data. When,
At least a part of the light from the light source is transmitted through the object at least once without passing through the standard sample so as to reach the detection unit, and data of the spectrum of light received by the detection unit Detecting as a measurement data,
Determining whether or not a foreign substance has entered the object based on the measurement data and the reference data.   The foreign matter inspection method according to claim 1, wherein the light emitted from the light source to the object is applied so as to cover the entirety of the object.   The foreign matter inspection method according to claim 1, wherein a wavelength of light emitted from the light source is not less than 600 nm and not more than 2500 nm.   3. The foreign matter inspection method according to claim 1, wherein a wavelength of light emitted from the light source is 800 nm or more and 1600 nm or less.   5. The object according to claim 1, wherein the target object is any one selected from the group consisting of a medicine, a pharmaceutical, an ingestible product for maintaining health, a nutrient, a granule, a powder, a film, and a capsule. Foreign matter inspection method.   The object is manufactured by a tableting method, and the light from the light source is transmitted through the object along the same direction as the direction that is pressed during the manufacturing by the tableting method. Item 6. The foreign matter inspection method according to any one of Items 1 to 5. A light source for irradiating light toward the object,
A detection unit that detects light emitted from the light source and transmitted through the object,
A storage unit for holding reference data,
A determination unit that determines whether a foreign object is included in the target object based on the data of the light detected by the detection unit and the reference data,
A first state in which the light from the light source passes through a standard sample having a thickness smaller than that of the target object without foreign matter reaching the detection unit at least once,
The light from the light source can be switched between a second state in which the light passes through the target unit at least once and reaches the detection unit,
The foreign matter inspection device, wherein the reference data is data obtained by the detection unit in the first state.   A holding unit for holding the object is provided, the holding unit supporting the object from below when the object is disposed at a position corresponding to the light transmitting unit and the member corresponding to the light transmitting unit. And a support extending over at least a part of the inner region of the light transmitting portion so that light traveling from the light source to the detection portion passes through the light transmitting portion in the second state. The foreign matter inspection device according to claim 7.   A holding unit for holding the object, the holding unit has a reflective surface, at least a portion of light once transmitted through the object is reflected by the reflective surface and transmitted through the object again The foreign matter inspection device according to claim 7, wherein the foreign matter is incident on the detection unit after the detection.   An apparatus for manufacturing the object, comprising a foreign matter inspection apparatus according to any one of claims 7 to 9.

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