WO2018135233A1 - Foreign matter detection device, foreign matter detection method and manufacturing device - Google Patents

Abstract

This foreign matter detection method, for determining whether or not foreign matter is admixed with a target, involves: a step for preparing a standard sample (20) that has no admixed foreign matter and that is thinner than the aforementioned target; a step in which light from a light source (6) passes through the standard sample (20) and reaches a detection unit (7) without passing through the target, and spectral data of the light detected by the detection unit (7) is acquired as reference data (11); a step in which at least some of the light from the light source (6) passes through the target at least once and reaches the detection unit (7), and spectral data of the light received in the detection unit (7) is detected as measurement data; and a step for determining whether or not foreign matter is admixed with the target on the basis of the measurement data and the reference data.

Description

Foreign object inspection apparatus, foreign object inspection method, and manufacturing apparatus

The present invention relates to a foreign matter inspection apparatus and a foreign matter inspection method. This application claims priority based on Japanese Patent Application No. 2017-005840, which is a Japanese patent application filed on January 17, 2017. All the descriptions described in the Japanese patent application are incorporated herein by reference. In particular, the present invention relates to a foreign matter inspection method and a foreign matter inspection apparatus that are also suitable for nondestructively determining the presence or absence of foreign matter mixed inside an object, for example, the presence or absence of organic matter such as hair and insects. The present invention further relates to a manufacturing apparatus.

-Increasing consumer awareness of safety has led to the close-up of foreign substances in products. For example, with the aging of the population, the number of rapidly disintegrating intraoral quick disintegrating tablets and tablets that can be chewed has increased. The case that becomes becomes easy to occur.

If foreign matter is mixed, it will cause anxiety and stress to consumers, and the products of manufacturers whose trust has been lost tend to be avoided. Furthermore, when foreign matter is mixed, a huge loss occurs because the recovery procedure prescribed by law is followed.

In such a foreign matter contamination problem, organic matters such as hair and insects are overwhelmingly found as foreign matters. Nevertheless, most foreign substance inspection devices introduced into production lines are for detecting foreign substances that can be detected by visual inspection, and inorganic substances that are easily detected by X-rays or magnetic force. . In the case where a foreign substance made of an organic substance is mixed in the object, it cannot be detected only by appearance inspection, and cannot be detected by X-ray or magnetic force inspection. For this reason, we had to resort to sampling inspection of the object or to prevent it by hygiene management.

For pharmaceuticals, there are examples of internal foreign matter analysis using X-ray computed tomography (X-ray CT), but it is only used as a research equipment for laboratories. There is no in-line technology that detects non-destructive and organic matter inside the object.

On the other hand, several methods have been studied to detect the contamination of foreign substances consisting of organic substances in food. An example is JP 2012-189390 A (Patent Document 1).

In Patent Document 1, based on hyperspectral images, a standard of 1940 nm to 2400 nm reflected / transmitted / scattered light with a clear hair peak is applied to foods and pharmaceuticals such as beans distributed on a belt conveyor. 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 Document 1 cannot be applied to an inspection object that is more scattered and absorbed by light than foods and pharmaceuticals placed in a distributed manner. For example, a tablet formed by compressing a powder into a solid has a large internal light scattering, and light absorption by a material such as starch used is too large in this wavelength region. If it is applied as it is, the feature relating to the foreign matter that should appear on the spectrum is covered and cannot be detected. In Patent Document 1, although light absorption by hair is observed, it cannot be detected even if foreign matter other than hair, such as insects, is mixed.

Therefore, an object of the present invention is to provide a foreign matter inspection apparatus and a foreign matter inspection method capable of determining the presence or absence of foreign matter mixed inside an object in a nondestructive manner. It is another object of the present invention to provide a manufacturing apparatus that can improve 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 foreign matter is mixed in an object, and is thinner than the object without foreign matter being mixed therein. A step of preparing a standard sample having a thickness; and light detected by the detection unit so that light from a light source passes through the standard sample and reaches the detection unit without passing through the object. Obtaining the spectrum data as reference data, and 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 detector as measurement data, and determining whether foreign matter is mixed in the object based on the measurement data and the reference data. And a step of.

According to the present invention, it is possible to determine non-destructively whether or not there is a foreign substance mixed inside the object.

It is a flowchart of the foreign material inspection method in Embodiment 1 based on this invention. It is sectional drawing of an example of the target object handled with the foreign material inspection method in Embodiment 1 based on this invention. It is sectional drawing of an example of the standard sample handled with the foreign material inspection method in Embodiment 1 based on this invention. It is explanatory drawing of a mode that process S1 of the foreign material inspection method in Embodiment 1 based on this invention is performed. It is explanatory drawing of a mode that process S2 of the foreign material inspection method in Embodiment 1 based on this invention is performed. It is a perspective view of the translucent part vicinity of the holding | maintenance part which can be used with the foreign material inspection method in Embodiment 1 based on this invention. It is sectional drawing of the holding part vicinity in the state in which the target object is mounted in the holding part of the 1st modification of the foreign material inspection apparatus in Embodiment 1 based on this invention. It is a top view of the holding | maintenance part vicinity of the 1st modification of the foreign material inspection apparatus in Embodiment 1 based on this invention. It is sectional drawing of the holding part vicinity in the state in which the target object is mounted in the holding part of the 2nd modification of the foreign material inspection apparatus in Embodiment 1 based on this invention. It is explanatory drawing of the example judged by calculating two indices and plotting on a graph. It is a conceptual diagram of the foreign material inspection apparatus in Embodiment 2 based on this invention. It is a conceptual diagram of the foreign material inspection apparatus in Embodiment 3 based on this invention. It is a conceptual diagram of the manufacturing apparatus in Embodiment 4 based on this invention.

(Embodiment 1)
With reference to FIGS. 1 to 10, a foreign substance inspection method according to the first embodiment of the present invention will be described. A flow chart of the foreign substance inspection method in this embodiment is shown in FIG. This foreign matter inspection method is a foreign matter inspection method for determining whether or not foreign matter is mixed in an object, and a step S0 of preparing a standard sample having no foreign matter mixed and having a thickness smaller than that of the target object. The light from the light source passes through the standard sample and reaches the detector without passing through the object, and the spectrum data of the light detected by the detector is acquired as reference data. Step S1, and 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, and is received by the detection unit. A step S2 of detecting light spectrum data as measurement data, and a step S3 of determining whether or not a foreign substance is mixed in the object based on the measurement data and the reference data.

This foreign matter inspection method determines whether or not foreign matter is mixed inside the object 1. An example of the object 1 is shown in FIG. A standard sample 20 prepared in step S0 is prepared for each object 1. An example of the standard sample 20 corresponding to the object 1 is shown in FIG. When the average thickness of the object 1 is T1, the thickness of the standard sample 20 is T2, and clearly T2 is smaller than T1. When there are a plurality of objects 1, it is considered that there is a variation in thickness due to manufacturing errors or the like. However, the thickness T <b> 2 of the standard sample 20 can be generated in consideration of the variation in the thickness of the object 1. The value is surely smaller than the minimum thickness. For example, the thickness T2 may be 90% or 80% of the 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 unclear whether or not foreign matter is mixed inside, but the standard sample 20 is a sample that is known in advance that foreign matter is not mixed inside. is there. It can be confirmed by a known technique such as optical CT (Computed Tomography) that no foreign matter is mixed inside. In step S0, a standard sample 20 that satisfies 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. Examples of use of the foreign substance inspection apparatus are shown in FIGS. 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 object inspection apparatus 101 holds a light source 6 for irradiating light toward 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. Storage unit 9 and a determination unit 10 that determines whether or not a foreign object is contained in the object 1 based on the light data 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 that is not mixed with foreign matters and has a thickness thinner than that of the object 1 and reaches the detection unit 7 at least once; and the light from the light source 6 Can switch between the second state that 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 apparatus 101 includes a holding unit 5 for holding the object 1.

Process S1 can be performed with the foreign object inspection apparatus 101 in the first state. FIG. 4 shows a state in which the foreign matter inspection apparatus 101 performs step S1. The holding unit 5 holds the standard sample 20 instead of the object 1. The light emitted from the light source 6 passes through the standard sample 20 instead of the object 1 and reaches the detection unit 7. Any condensing part may be transmitted between the standard sample 20 and the detection part 7. The condensing unit may be a lens, for example. The condensing unit may be a lens 5d as shown in FIG. In this example, the lens 5 d is provided inside the hole 5 a as a part of the holding portion 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 displayed for convenience of explanation, but the standard sample 20 itself is not a part of the foreign matter inspection apparatus 101.

Process S2 can be performed with the foreign matter inspection apparatus 101 in the second state. FIG. 5 shows a state in which the step S2 is performed by the foreign matter inspection apparatus 101. The holding object 5 holds the object 1. The 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 explanation, but the object 1 itself is not a part of the foreign matter inspection apparatus 101.

(Object)
The object 1 may be a tablet, for example. The object 1 may have a flat shape. The object 1 may be formed by solidifying a powder. The object 1 may be a medicine or a food. The object 1 may be something in which some content is contained in the capsule. The capsule here may be a soft capsule.

* Organic substances such as hair and insects are assumed to be detected as foreign substances by inspection. A resin piece or the like may be included in what should be detected as a foreign object.

(light source)
The light source 6 may include a halogen lamp. The wavelength of light may be 600 nm or more and 2500 nm or less, for example. Although the wavelength of the light to irradiate is not limited to this range, in this wavelength range, it is easy to transmit through the object 1 and does not damage the object 1 as when irradiated with ultraviolet rays. ,preferable. Furthermore, the wavelength of light may be, for example, not less than 800 nm and not more than 1600 nm. The wavelength of the irradiated light is not limited to this range, but there are large absorption peaks such as starch, lactose, and crystalline cellulose contained in general tablets in the vicinity of 1600 nm of the wavelength of the light. The influence on the spectrum due to is hidden. Moreover, if the wavelength is too short or too long, light loss due to light scattering, absorption, etc. will increase. Therefore, in the present embodiment, the wavelength of light to be irradiated is preferably 800 nm or more and 1600 nm or less. In the present embodiment, a halogen lamp is used as an example of the light source 6, but the type of the light source is not limited to this and may be other types of lamps. The light source 6 only needs to be a device that can emit light having a wavelength that can detect foreign matter, and may be, for example, a tungsten lamp, a phosphor, an LED, or a laser.

Note that 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 the present invention is not limited to this, and the light is irradiated simultaneously from different directions using two or more light sources. May be.

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

(Light adjustment part)
The light adjustment unit 12 adjusts the traveling direction of light from the light source 6. As already described, the light adjustment unit 12 includes, for example, a lens. The irradiation light is irradiated while covering the entire object 1 in a lump so that even foreign objects mixed in the end of the object 1 can be detected. The light adjustment unit 12 is focused so that such irradiation can be performed. However, if the light irradiation area is too larger than the object 1, the portion of the irradiated light that is wasted increases, so the irradiation area is set to be slightly larger than the projected area of the object 1. For example, the area of the irradiation region may be 100.1% of the projected area of the object 1. The “projected area of the object 1” here is an area obtained by projecting the object 1 onto a virtual plane perpendicular to the light irradiation direction.

For example, when the 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 when the tablet is manufactured. In general, in the tableting method in which molding is performed with a mortar and a punch, the outer peripheral surface of the tablet is hard and light is difficult to transmit. Therefore, it is possible to facilitate the transmission of light by irradiating light so that it enters from other than the outer peripheral surface. In addition, the irradiation direction of light is not limited to this, and irradiation may be performed from an appropriate direction according to the inspection state of the foreign matter.

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

The light adjusting unit may guide the light after coming out of the light source body to a desired position with a light guide made of, for example, an optical fiber. The light adjusting unit may have a configuration in which a lens is disposed at the tip of such a light guide. In this case, although light loss may occur inside the light guide means, there is an advantage that light irradiation can be easily performed from a position close to the object.

The light adjusting unit 12 may include a shutter that blocks light. When the shutter is provided as described above, the shutter is closed to block the light in accordance with the conveyance of the object so that the light from the object 1 that has been measured does not enter the detection unit 7 and become noise. Can do. In addition, when the shutter is provided in this way, even when it is desired to temporarily stop light irradiation for sample exchange or the like to perform some work, the shutter is closed, and the light source is kept on and the external light is kept on. In this case, it is possible to realize a state in which light is not irradiated, and a desired operation 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 translucent part. A perspective view of the vicinity of the hole 5a of the holding portion 5 is shown in FIG. The hole 5 a 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 slight. As shown in FIGS. 4 and 5, the holding portion 5 includes a first portion 5 b, a second portion 5 c, and a lens 5 d. The first portion 5b is made 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 on the upper side of the second portion 5c but also on the lower side. 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 5 c 1 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 5 d is for condensing 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 is less permeable 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 material having low permeability 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 part 5 has a hole 5a, and the object 1 is held by being placed inside the hole 5a, but this is only an example. The object 1 is not limited to the hole as long as the object 1 can be held and the passage of the transmitted light can be secured to a sufficient extent to measure 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 to prevent the transmitted light from being blocked 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 is in contact with the second portion 5c. This ratio is not limited to 90%, and may be 95%, for example.

In the example shown here, the second portion 5c is plate-shaped and may be referred to as a “support plate”. Here, an example in which the second portion 5c has transparency with respect to the wavelength of the transmitted light is shown. In this case, the second portion 5c may be formed using a transparent member having a wavelength characteristic that transmits light. As a material of the second portion 5c, for example, quartz glass or synthetic quartz glass can be employed. When the 2nd part 5c has transparency, the light which permeate | transmitted the target object can be utilized efficiently.

The second portion 5c is not limited to being transparent with respect to the wavelength of transmitted light. The second portion 5c can be configured to be translucent or opaque. In the case where the second portion 5c is not light-transmitting, the selection range of the material is widened, so that a material that can easily hold the object can be selected. Further, depending on the shape of the object, the ratio of noise light passing through the gap between the object 1 and the holding unit 5 may increase. However, if the second portion 5c is opaque, such noise light may be emitted. Can be blocked.

(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 condensing unit before entering the detection unit 7. The condensing unit may be, for example, a lens 5 d provided as a part of the holding unit 5, or may be provided separately from the holding unit 5. The condensing unit may include some kind of lens or may contain some kind of reflecting plate. The light may be guided from the holding unit 5 to the detection unit 7 by a light guide made of an optical fiber.

A shutter for blocking light at the entrance of the detection unit 7 may be disposed in a freely openable / closable state. In this way, the light can be blocked by closing the shutter so that the light from the object that has been measured does not enter the detector 7 and become noise. In addition, if the shutter is arranged in this way, it is advantageous in that the light can be blocked when it is desired to temporarily prevent the strong light from entering the detection unit 7.

For the detection unit 7, for example, a polychromator type spectroscope may be used. In a polychromator type spectroscope, a large number of light receiving elements are arranged at the end of a prism that divides light into each wavelength, and light of each wavelength can be measured simultaneously. The polychromator type spectrometer is also called a multi-channel detector. The polychromator type spectrometer has the advantage of high measurement time.

Polychromators include those using a light receiving element and a prism, and those using a CCD. The type of polychromator is appropriately selected according to the configuration of the inspection apparatus, the type of tablet to be measured, the wavelength of light, and the like. In this embodiment, as an example, a system in which an InGaAs light receiving element and a prism, which are more accurate than a CCD, are combined is used.

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

(Control part)
As shown in FIGS. 4 and 5, the foreign substance inspection apparatus 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 control the opening and closing of the shutter. Each process by the control part 13 may be implement | achieved by the central processing unit (CPU: Central Processing Unit).

(Judgment part)
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 foreign matter mixed in the object 1. Whether or not is included is determined. In the example shown here, the determination unit 10 is illustrated 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.

(Memory part)
The storage unit 9 is for storing information necessary for inspection. The storage unit 9 includes, for example, an area for temporarily storing measurement data from the detection unit 7, various programs executed by the control unit, an area for storing data used in these programs, and these programs. An area to be loaded and a work area used when these programs are executed are provided. Here, the various programs 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 foreign substance inspection method)
The work flow when performing the inspection based on the foreign matter inspection method in the present embodiment will be described more specifically. Here, although it demonstrates as performing using the foreign material inspection apparatus 101, the same view can be applied also when performing using another apparatus.

Prior to the inspection, the lens of the light adjusting unit 12 is previously focused so that the irradiation light covers the target 1 when the target 1 is in the holding unit 5. That is, the focus is adjusted 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 object 1, the proportion of wasted light in the entire light increases, so the irradiation area is set to be slightly larger than the object 1. Here, it is 100.1% of the total cross-sectional area.

Measurement conditions that can be artificially changed, such as the irradiation time of light, the amount of irradiation light, the slit width of the spectrometer, the integration time, the average number of times, the set temperature, and the sensitivity, are predetermined according to the type of the object 1 and We will not change these conditions during this period.

The holding unit 5 present at the measurement position holds one object 1 and irradiates light for each object 1 for a certain period of time. The light irradiation time is set to a time short enough to avoid inappropriate heating of the object 1. In the present embodiment, the irradiation time is 0.8 seconds per time.

If stray light from another holding unit 5 can be prevented by irradiating each holding unit 5 individually instead of irradiating a plurality of holding units 5 all at once. The light source 6 only needs to be a light source that can irradiate light for a short time. In addition to electrical control, for example, a flash-type lamp or chopper may be used.

In the present embodiment, irradiation is performed for a short time of 0.8 seconds per 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 object 1, so the irradiation time may be lengthened depending on the type of the object 1. However, since the irradiation light includes heat rays, the object 1 is heated when irradiated with light. The temperature rises as the amount of light to be irradiated is increased and the irradiation time is lengthened. Depending on the type of the object 1, the component is altered by being heated too much. In the case where the object 1 has already been heated and heated in a drying process or the like prior to the inspection process, the temperature is set as the upper limit. This is because the temperature in the drying step or the like performed before is generally kept below the temperature at which the components of the object 1 are altered. 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 any process performed before the inspection process, and the amount of irradiation light is made as large as possible within the range satisfying this condition, and the measurement time Is preferably shortened. The upper limit of the irradiation time and the irradiation light amount is appropriately determined depending on the component and structure of the object 1.

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

Various modifications can be considered for the foreign matter inspection apparatus according to the first embodiment of 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 modification, the holding part 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 of the state in which the object 1 is placed on the holding unit 5, and FIG. 8 is a plan view of the vicinity of the holding unit 5 without the object 1. In this example, the three protrusions 5e are provided at equal intervals of about 120 °. The number of protrusions 5e may be other than three. The arrangement angles of the protrusions 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 part 5 includes a first part 5b, a second part 5c, and a lens 5d, and the second part 5c has an opening. The opening of the second portion 5c has a mortar shape. It is preferable that the opening part of the 2nd part 5c becomes a mortar shape that the shape of the target object 1 fits.

First, before inspecting the object 1, a measurement for obtaining 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 matter inspection apparatus 101 in the first state. In other words, the standard sample 20 is placed in the holding unit 5 instead of the object 1 and is irradiated with light.

It should be noted that when the time has elapsed since the previous acquisition of the reference data 11 or when the type of the object to be inspected is changed, it is determined whether or not the measurement for acquiring the reference data 11 is to be performed again. The selection is appropriately made 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 obtaining the reference data 11 is performed, for example, 1 day before the start of the morning inspection and before the start of the afternoon inspection. You only have to do it once. The ND filter used at this time is determined according to the type of the object. Usually, if the type of the object changes, what should be prepared as a standard sample also changes, so step S0 needs to be performed.

(1st step: Measurement of reference data)
This is a measurement performed with the foreign object inspection apparatus 101 in the first state.
1. A standard sample 20 corresponding to the object 1 is prepared.
2. Instead of the object 1, the holding unit 5 in which the standard sample 20 is installed is arranged in the light irradiation region.
3. Turn on the light source. Thereby, the light from the light source 6 enters the light adjusting unit 12. The light adjusting unit 12 performs some adjustment on the light as necessary. The adjustment is, for example, correction of the optical path.
4). The light from the light adjusting unit 12 is transmitted through the standard sample 20. Here, “transmission” includes passing through the standard sample 20 while being scattered (including multiple scattering). Thereafter, the light is collected by the lens 5 d and enters the detection unit 7. The spectrum of light (the intensity of light 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 I0.

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

(3rd stage: Judgment of foreign matter contamination)
10. The determination unit 10 performs conversion for extracting information on the foreign matter from the difference between the incident light and the transmitted light using the measured light intensity. In the present embodiment, the absorbance for each wavelength is calculated as absorbance A1 = log (I0 / I). Note that when the object 1 is a tablet, scattering of light inside is large, and therefore, A1 cannot be strictly called absorbance, but for convenience, this A1 is defined as absorbance.
11. The determination unit 10 determines the presence or absence of foreign matter from the calculated absorbance A1.

In this embodiment, discriminant analysis is used. Specifically, a calculation model for calculating the class predicted value and the similarity of the sample from the absorbance is used. The calculation model derivation method includes support vector machine, pattern recognition, Mahalanobis distance analysis, SIMCA (Soft Independent Modeling of Class Analysis) discriminant analysis, canonical discriminant analysis method and the like. The calculation model may be determined by selecting an optimum derivation method according to the purpose of what kind of object to be determined.

Here, a calculation model for determining the characteristics of a foreign substance contained in a tablet as a target object is derived by the PLS-DA (Partial Linear Square-Discriminant Analysis) method, and the value calculated from the tablet measurement data using this calculation model is Foreign matter contamination is determined based on whether or not the reference value is greater than a preset reference value. A calculation model for performing the calculation is determined by the wavelength of light to be irradiated, the type of tablet, the configuration of the transport unit of the inspection apparatus, 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 in the detection unit 7 and the calculation model for each type of tablet read from the database stored in the storage unit 9 to calculate an index indicating the characteristics of the tablet. The presence / absence of foreign matter is determined.

The determination unit 10 can make a determination using a relational database or a correspondence table, or a plot using a graph as appropriate, depending on 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 the tablet is a normal tablet or a tablet mixed with hair. If the predicted value calculated from the calculation model is 0.5 or more and the bias value is less than 0.5, it is “normal”, and if the predicted value is less than 0.5 and the bias value is less than 0.5, “hair is mixed. Can be determined. In addition, when the predicted value is less than 0.5 and the deviation 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 cracking occurs. It can be considered that there is a high possibility. In this case, the type of abnormality can be specified using still another calculation model. For example, if an index indicating whether the tablet is a normal tablet or a tablet in which insects are mixed can be calculated, the presence or absence of insects can be detected.

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

Whether to use only one index as shown in Table 1 or whether to use a plurality of indices for plotting as shown in FIG. 10 depends on the type of tablet and how closely the user performs the inspection. May be determined as appropriate. Further, the reference values shown in Table 1 and the reference straight line shown in FIG.

(When a foreign object is detected)
12 The target object 1 determined to be contaminated with foreign matter or the lot including the same is discarded. In the determination of contamination, there may be a situation where the cause of the abnormality cannot be identified although it is known that the abnormality is present. Even in such a case, it is desirable to discard the target object 1 or a lot including the same. For example, although it is known to be abnormal, it may be unclear whether it is hair contamination, insect contamination, or otherwise. In the present embodiment, even if no organic foreign matter is mixed, even if an inorganic foreign matter is mixed, or if there is an abnormality such as a crack inside even if no foreign matter is mixed, it is not normal. It may be detected as a result.

According to the present embodiment, it is possible to determine the presence or absence of foreign matter mixed inside the object 1 in a nondestructive manner. In the present embodiment, the sample having a thickness smaller than that of the object 1 is used as the standard sample. Therefore, the amount of light transmitted through the object is surely smaller than the amount of light transmitted through the standard sample. . Therefore, when the determination unit 10 calculates the absorbance, 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 with a tableting machine, the degree of pressurization varies, resulting in a difference in density and thickness in each manufactured tablet. Tend to occur. If the present embodiment is not used, the absorbance may become almost zero or a negative value due to this manufacturing variation, and in such a situation, the determination accuracy of the presence or absence of foreign matter deteriorates. It is thought that it will end. However, according to the present embodiment, it is possible to ensure that the absorbance has a positive value even if there is a manufacturing variation, and therefore it is possible to avoid deterioration in the determination accuracy of the presence or absence of foreign matter.

In the foreign matter inspection method in the present embodiment, it is preferable that the light irradiated from the light source 6 to the object 1 is irradiated so as to cover the entire object 1. The irradiated light can be inspected to some extent even if it does not cover the entire object 1, but it is preferable to cover the entire object in order to perform an accurate inspection.

In the foreign matter inspection method in the present embodiment, the wavelength of light emitted from the light source 6 is preferably 600 nm or more and 2500 nm or less. Furthermore, the wavelength of light emitted from the light source 6 is preferably 800 nm or more and 1600 nm or less. The reason is as described in the explanation regarding the light source.

The foreign matter inspection apparatus 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 translucent part and the object inside the translucent part. And a support portion that extends to cover at least a part of the inner region of the translucent portion so as to support the object from below. In the second state, the light source 6 moves toward the detection portion 7. It is preferable that the light passes through the translucent part. Here, the “translucent portion” may be, for example, the hole 5a shown in FIGS. The hole 5a is a through hole. However, the translucent portion is not limited to the through hole, and may be a portion where light can pass through anyway. Therefore, the translucent part may be a gap between some members, for example. The translucent portion may be a portion where some translucent member is disposed. It may be a portion that is partially or completely blocked by some translucent member. Here, the “supporting portion” may be a portion in which the second portion 5c shown in FIGS. 4 to 6 projects to the inside of the hole 5a, for example. The support portion is not limited to projecting over the entire circumference in this way, and one or more projections may project inward. The support portion may be a projection 5e shown in FIGS.

The support part may be transparent. By adopting this configuration, the degree to which the support portion blocks the transmitted light 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 factor of the ND filter is known in advance, foreign matter can be more accurately determined by correcting the standard data based on the wavelength dependence. Further, an appearance inspection may be additionally performed before or after performing the foreign matter inspection method according to the present invention. As described above, if the appearance inspection is further combined with the foreign matter inspection method in the present embodiment, the foreign matter can be detected more reliably.

Further, the storage unit 9 may record inspection results and inspection data such as date and temperature. For example, records concerning the status of other devices, such as the number and time of people entering and leaving a certain space, the materials used, the timing of washing the tablet press, the presence or absence of a fluorescent lamp breakage accident, etc. Good. If combined with these data and analyzed, they can be presented as comprehensive data for preventing foreign matter contamination. That is, it can be utilized as a means for preventing the recurrence of foreign matter contamination.

(Embodiment 2)
With reference to FIG. 11, the foreign substance inspection apparatus in Embodiment 2 based on this invention is demonstrated.

In the first embodiment, an example in which light is applied to the object 1 from one direction using one light source 6 is shown. However, the present invention is not limited to this, and two or more light sources are used from different directions. It may be irradiated. In the foreign substance 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 6 a and 6 b. 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 5 d. The configuration of other parts, the usage method, and the like 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 effects as described in the first embodiment can be obtained also by the foreign substance inspection apparatus in the present embodiment.

(Embodiment 3)
With reference to FIG. 12, the foreign substance inspection apparatus in Embodiment 3 based on this invention is demonstrated.

In the first embodiment, the light transmitted through the object 1 is received by the detection unit 7, but not only the transmitted light but also reflected light may be used. In the foreign matter inspection apparatus 103 in 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 the light transmitted through the object 1. By irradiating the object 1 with light from the light source 6, the light transmitted through the object 1 is reflected by the bottom surface of the concave portion of the holding unit 5 and is transmitted again through the object 1. In this way, the light transmitted through the object 1 and traveling in the direction 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 part of the light that has once transmitted through the object 1 is the reflecting surface. , And then again passes through the object 1 before entering the detection unit 7. The configuration of other parts, the usage method, and the like 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 effects as described in the first embodiment can be obtained also by the foreign substance inspection apparatus in the present embodiment. In the present embodiment, since the light reaches the detection unit 7 after passing through the inside of the object 1 twice, a more accurate inspection can be performed.

(Embodiment 4)
With reference to FIG. 13, the manufacturing apparatus in Embodiment 4 based on this invention is demonstrated. The manufacturing apparatus in this Embodiment is an apparatus for manufacturing the target object 1, Comprising: It is a manufacturing apparatus provided with the foreign material inspection apparatus of one of the structures demonstrated so far. This manufacturing apparatus is shown in FIG. What 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 production unit 301 that produces the object 1, and further includes a foreign substance inspection apparatus 101. The object 1 produced by the production unit 301 is inspected by the foreign substance inspection apparatus 101. The conveyance of the object 1 to the foreign matter inspection apparatus 101 is performed by, for example, the conveyance apparatus 302. The conveyance device 302 conveys the object 1 stored in the cassette. The conveyance device 302 shown here is merely an example, and is not limited to such a form.

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

In the present embodiment, the production unit 301 and the foreign substance inspection apparatus 101 are shown as apparatuses that are housed in separate housings. However, this is merely an example, and the two are integrated. And may be housed in a single housing.

In each of the embodiments described so far, a tablet, that is, a tablet is shown as the target object 1. However, the present invention is not limited to a tablet form, and can be applied to a powder, a granule, a capsule, and a film. The object 1 may be, for example, a medicine, a drug, a food, a health maintenance intake, and the like. The object 1 may be any one selected from the group consisting of medicines, pharmaceuticals, health maintenance intakes, nutrients, granules, powders, films, and capsules.

In the foreign matter inspection method in each embodiment, the object 1 is manufactured by the tableting method, and the light from the light source 6 is along the same direction as the direction pressed during the manufacturing by the tableting method. Thus, it is preferable to pass through the object 1. This is because the light transmittance is improved in this direction.

In addition, you may employ | adopt combining suitably two or more among the said embodiment.
In addition, the said embodiment disclosed this time is an illustration in all the points, Comprising: It is not restrictive. The scope of the present invention is defined by the terms of the claims, and is intended to include any modifications within the scope and meaning equivalent to the terms of the claims.

1 object, 5 holding part, 5a hole, 5b first part, 5c second part, 5c1 opening part, 5d lens, 6 light source, 7 detection part, 9 storage part, 10 determination part, 11 reference data, 12 light adjustment Unit, 13 control unit, 20 standard sample, 101, 102, 103 foreign matter inspection device.

Claims (10)

A foreign matter inspection method for determining whether foreign matter is mixed in an object,
A step of preparing a standard sample having a thickness smaller than the object without foreign matter mixed therein;
A step of acquiring light spectrum data detected by the detection unit as reference data so that light from a light source passes through the standard sample and reaches the detection unit without passing through the object. When,
Spectral data of light received by the detector 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 detector. Detecting as measurement data,
A foreign matter inspection method including a step of determining whether foreign matter is mixed in the object based on the measurement data and the reference data. The foreign matter inspection method according to claim 1, wherein the light irradiated from the light source to the object is irradiated so as to cover the entire object. The foreign matter inspection method according to claim 1 or 2, wherein a wavelength of light emitted from the light source is 600 nm or more and 2500 nm or less. The foreign matter inspection method according to claim 1 or 2, wherein the wavelength of light emitted from the light source is not less than 800 nm and not more than 1600 nm. 5. The object according to claim 1, wherein the object is any one selected from the group consisting of drugs, pharmaceuticals, health maintenance intakes, nutrients, granules, powders, films, and capsules. Foreign substance inspection method. The object is manufactured by a tableting method, and light from the light source passes through the object along the same direction as the direction of pressure applied during manufacture by the tableting method. Item 6. A foreign matter inspection method according to any one of Items 1 to 5. A light source for irradiating light toward the object;
A detector that detects light emitted from the light source and transmitted through the object;
A storage unit for storing reference data;
A determination unit that determines whether or not a foreign object is included in the object based on the light data detected by the detection unit and the reference data;
A first state in which light from the light source is transmitted at least once through a standard sample that is not contaminated with foreign matter and has a thickness smaller than the object;
The light from the light source can be switched between a second state where the light passes through the target part at least once and reaches the detection part,
The foreign matter inspection apparatus, wherein the reference data is data obtained by the detection unit in the first state. A holding part for holding the object is provided, and the holding part supports the object from below when the object is arranged at a position corresponding to the member having a light transmitting part and the light transmitting part. And a support portion extending to cover at least a part of the inner region of the light transmitting portion, and in the second state, light traveling from the light source toward the detection portion passes through the light transmitting portion. The foreign matter inspection apparatus according to claim 7. A holding unit for holding the object, the holding unit having a reflecting surface, and at least a part of the light that has once transmitted through the object is reflected by the reflecting surface and is transmitted through the object again; The foreign matter inspection apparatus according to claim 7, which enters the detection unit after a while. An apparatus for manufacturing the object, the manufacturing apparatus comprising the foreign matter inspection apparatus according to any one of claims 7 to 9.

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