JP2003287503A - Quality control method of powder and granular material, and foreign material sample used for it - Google Patents

Abstract

(57) [Summary] [PROBLEMS] To inspect the presence or absence of foreign matter in a granular material,
Provided are a quality control method for a granular material capable of easily collecting a foreign substance sample used for detection confirmation in advance, and a foreign substance specimen used for the method. SOLUTION: In the quality control method of a granular material, a foreign material detecting device 20 checks whether or not a foreign material is present in the granular material being conveyed on a belt conveyor 4. Belt conveyor 4
Foreign matter 3 sealed with two transparent crimpable thin films 31 in the granular material to be conveyed or on the belt conveyor 4
2 as a foreign substance sample 30 and the belt conveyor 4 is operated, and the foreign substance sample 30 is
And removing the foreign substance sample 30 when the foreign substance 32 of the foreign substance sample 30 is detected by the foreign substance detection device 20.

Description

Detailed Description of the Invention

[0001]

BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to a method of quality control of powdery granules for maintaining a constant quality of powdery granules such as oral pharmaceutical powdery granules, and a foreign matter sample used for the quality control method. More specifically, the present invention relates to a method for confirming whether a device that detects a foreign substance that may be contained in a powder or granular material is operating normally.

[0002]

2. Description of the Related Art Conventionally, it has been difficult to detect and remove foreign substances from powders of pharmaceuticals used as oral preparations. In particular,
It was difficult to detect and remove foreign matter and hair smaller than the diameter of the oral pharmaceutical powder.

Recently, for example, Japanese Patent Laid-Open No. 2000-84.
As disclosed in Japanese Patent Publication No. 496 (publication date March 28, 2000) and Japanese Patent Application Laid-Open No. 2000-162136 (publication date June 16, 2000), a light source and an electric coupling are used as a foreign matter detection means. Device (CCD: Charge Coupled Dev)
An apparatus for detecting a foreign substance in an oral pharmaceutical powder has been developed, which uses a means in combination with an ice camera (hereinafter abbreviated as “CCD camera”). Specifically, this device operates as follows, for example. (1) Oral drug powder powder charged in the oral drug powder hopper is supplied to the oral drug powder dispersion feeder by the quantitative supply device. (2) The oral pharmaceutical powder is supplied in a single layer from the oral pharmaceutical powder dispersion feeder to a conveying means such as an inspection conveyor having an electrostatic remover and a dust collector. (3) A light source such as a strobe lighting device is arranged above and below the inspection conveyor, and the oral pharmaceutical powder on the conveying means is passed through the inside of the detection device having a CCD camera or the like as a detector. (4) When a foreign substance is detected in the oral pharmaceutical powder on the conveying means, the conveying means is stopped or the foreign substance is collected in the defective storage tank. On the other hand, when there is no foreign substance, the oral pharmaceutical powder is discharged to the outside of the machine through the non-defective chute.

It should be noted that the apparatus itself does not have a mechanism for checking the detection sensitivity or checking whether there is an abnormality in the detection sensitivity.

[0005]

By the way, in the oral pharmaceutical powder foreign matter inspection apparatus used in the above-mentioned conventional quality control method for powdery or granular material, the sensitivity of the detector may be deteriorated due to deterioration of the light source or dirt. is there. Therefore, it is possible to confirm whether or not the foreign matter detector can detect the foreign matter, or whether the foreign matter detector is operating normally.
It was necessary for quality control in the manufacturing process of oral pharmaceutical powder.

However, in the above-mentioned conventional oral drug powder foreign substance inspection apparatus, when the foreign substance sample is mixed into the oral pharmaceutical powder and the operation of the foreign substance detector is inspected, only the foreign substance is removed because the foreign substance itself is small. It is difficult to do so.

Further, when the mixed foreign matter sample cannot be detected, the mixed foreign matter cannot be collected, and as a result, the sample is passed through the detector again or all the oral pharmaceutical powders in the batch are collected. It had to be discarded.

That is, in this way, it is difficult to remove the foreign matter sample by mixing it with the oral pharmaceutical powder to be the product, since it becomes a true foreign matter and it is difficult to remove it visually. There was a situation of doing.

The present invention has been made in view of the above-mentioned conventional problems, and an object thereof is to easily collect a foreign matter sample used in advance for detection and confirmation when inspecting the presence or absence of foreign matter in a powder or granular material. (EN) Provided are a quality control method for a powdery granular material, and a foreign matter sample used for the method.

[0010]

DISCLOSURE OF THE INVENTION The present inventors have diligently studied to solve the above-mentioned problems, and a foreign matter detecting method capable of easily collecting a foreign matter sample by sandwiching a foreign matter between two transparent thin films. As a result of the discovery and further study, the present invention has been completed.

That is, in the foreign matter inspection device used for the quality control method of powdery or granular material, the sensitivity of the detector may decrease due to deterioration of the light source, dirt, etc.
It is necessary to confirm whether or not foreign matter can be detected by the foreign matter detector. This confirmation is carried out by actually mixing the sample of foreign matter into the product, but there is a problem that the collection is not always easy.

Therefore, in order to solve the above-mentioned problems, the quality control method for powdery or granular material according to the present invention detects the presence or absence of foreign material in the powdery or granular material being conveyed by the powdery or granular material conveying means. In the quality control method for powdery or granular material to be inspected by means, a transparent two crimpable thin film is used for sealing in or on the powdery or granular material carrying means by the powdery or granular material carrying means. A step of placing the foreign matter as a foreign matter sample, a step of operating the powdery granular material conveying means, passing the foreign matter sample through the foreign matter detecting means, and a foreign matter of the foreign matter sample being detected by the foreign matter detecting means, And a step of removing the foreign matter sample.

According to the above-mentioned invention, the foreign matter sealed in the powdery granular material conveyed by the powdery granular material conveying means by the transparent two crimpable thin films is a foreign matter. A step of placing as a sample, a step of operating the powder / granular body conveying means to pass the foreign matter sample through the foreign matter detecting means, and a step of removing the foreign matter sample when a foreign matter of the foreign matter sample is detected by the foreign matter detecting means The process is included.

Therefore, since the foreign matter is a foreign matter sample sealed by two transparent thin press-bondable thin films, it can be easily distinguished and collected from the granular material.

As a result, when inspecting the presence or absence of foreign matter in the powdery or granular material, it is possible to provide a quality control method for the powdery or granular material, which can easily collect the foreign material sample used for detection and confirmation in advance.

Further, the quality control method for powdery or granular material according to the present invention is the method for quality control for powdery or granular material as described above, wherein the foreign material of the foreign material sample is fiber, hair or 0.1 mm.
It is characterized by having the above size.

According to the above invention, the foreign matter in the foreign matter sample is
Since it is a fiber or hair, or has a size of 0.1 mm or more, it is possible to confirm the detection of the fiber or hair, and to use a commonly used foreign object detection means such as a CCD camera. It is possible to detect foreign matter that exceeds the detection limit.

The quality control method for powdery or granular material of the present invention is characterized in that in the quality control method for powdery or granular material described above, the powdery or granular material is an oral pharmaceutical product.

According to the above invention, since the powdery granules are oral medicines, when the presence or absence of foreign matter in the oral medicine powdery granules is inspected, the foreign matter sample used for detection and confirmation in advance can be easily collected. It is possible to provide a quality control method for a granular material.

Further, in the quality control method for powdery or granular material according to the present invention, in the quality control method for powdery or granular material described above, the powdery or granular material conveying means is a conveyor, a turntable, a vibration feeder, or an electromagnetic feeder. It is characterized by that.

According to the above-mentioned invention, since the powdery or granular material conveying means is a conveyor, a turntable, a vibrating feeder or an electromagnetic feeder, a general conveying means can be used. In addition, it is possible to easily secure a region in which the powder particles are dispersed in a plane.

Further, the quality control method for powdery or granular material according to the present invention is the method for quality control for powdery or granular material as described above, wherein the foreign matter detecting means is a lighting device and an electrically coupled device (CCD).
It is characterized by having a camera.

According to the above invention, since the foreign matter detecting means is provided with an electrically coupled device (CCD) camera,
It is possible to detect a foreign substance based on the difference in brightness and color.

Further, by providing the illuminating device, it is possible to brighten the whole powdery granular material and increase the detection sensitivity.

Further, the quality control method for powdery or granular material according to the present invention is the method for quality control for powdery or granular material as described above, wherein the electrically coupled device camera is a line sensor electrically coupled device camera or an area sensor electrically coupled device camera. It is characterized by being.

According to the above invention, when the electrically coupled device camera is the line sensor electrically coupled device camera, it is possible to confirm the presence of foreign matter in the line of the granular material, so that the granular material moving in the conveying direction is detected. The presence of foreign matter can be detected along the line perpendicular to the body in the carrying direction.

When the electrically coupled device camera is an area sensor electrically coupled device camera, the presence of foreign matter can be detected for a certain area of the powdery or granular material.

Further, in the quality control method for powdery or granular material according to the present invention, in the quality control method for powdery or granular material described above, the illumination device of the foreign matter detecting means uses a strobe or a halogen lamp as a light source. Is characterized by.

According to the above invention, since the illumination device of the foreign matter detecting means uses the strobe or the halogen lamp as the light source, it is suitable for detecting the foreign matter in the foreign matter detecting means equipped with a CCD camera, for example. It can be used as a light source.

In order to solve the above-mentioned problems, the foreign matter sample of the present invention is used in the above-mentioned quality control method for powdery or granular material, and comprises two transparent thin films which can be crimped and two thin films. It is characterized by consisting of a sealed foreign substance.

According to the above invention, the foreign matter sample is used for the quality control method of the above-mentioned powdery or granular material, and is composed of two transparent thin films which can be crimped and a foreign matter which is sealed by these two thin films. Become.

Therefore, when inspecting the presence or absence of foreign matter in the powdery or granular material, it is possible to provide a foreign matter sample from which a foreign matter sample used for detection and confirmation in advance can be easily collected.

The foreign matter sample of the present invention is the foreign matter sample described above, wherein the thin film has a side of 5 mm to 30 mm.
It is characterized in that it has a polygonal shape having a size of, or a circular shape or a substantially circular shape having a diameter of 5 mm to 30 mm. In addition, preferably, one side is 5 mm to 20 m.
A polygon having a size of m, or a diameter of 5 mm to 20 mm
It has a circular shape or a substantially circular shape having a size of.

According to the above invention, the thin film has a side of 5 m.
polygon having a size of m to 30 mm, or a diameter of 5 mm
It consists of a circle or a circle with a size of -30 mm.

Therefore, even if it is mixed in the powder or granular material, it can be easily distinguished from the powder or granular material and collected.

[0036]

BEST MODE FOR CARRYING OUT THE INVENTION An embodiment of the present invention will be described below with reference to FIGS. In the present embodiment, an oral pharmaceutical powder is described as an example of the powdery granules, but the powdery granules are not limited to this, and other powdery granules may be used.

There are no particular restrictions on the oral pharmaceutical powder as a powder / granular material applied to the quality control method for powder / granular material of the present embodiment, as long as it is a granule, a fine granule or a powder used as an oral preparation. Absent.

The above granule means 10 mesh (170
0 mesh), less than 5% remains on 12 mesh (1400 μm) and 42 mesh (355 μm)
It means that 15% or less pass through m). Further, the fine granules are those which meet the powder standard and have 5% or less of those remaining on 200 mesh (75 μm).
Furthermore, powder is 5% after passing through 18 mesh (850 μm) and remaining at 30 mesh (500 μm).
Refers to the following:

Examples of the above oral preparations include pharmaceuticals, vitamin preparations, sweeteners and the like. Preferred examples include pharmaceuticals in which contamination by foreign matter is a particular problem.

First, the powder / granular substance inspection apparatus used in the quality control method of the powder / granular substance of the present embodiment will be described.

As shown in FIG. 2, the powder / granular material inspection device 10 has a granule hopper 1, a constant amount supply device 2, a granule dispersion feeder 3, a powder / granular material conveying means and a belt conveyor 4 as a conveyor, A foreign matter detection device 20 as foreign matter detection means and a defective product collection device 5 are provided.

The above-mentioned granule hopper 1 is for storing the oral pharmaceutical powder, has an openable lid for charging the oral pharmaceutical powder from the top, and for making it difficult for foreign matter such as dust to enter. It is possible to transfer the oral pharmaceutical powder to the fixed quantity supply device 2. Therefore, this hopper type granular hopper 1 is preferable as a storage for the oral pharmaceutical powder.

The quantitative supply device 2 supplies a fixed amount of the oral pharmaceutical powder stored in the granule hopper 1. The granule dispersion feeder 3 is provided with a feeder plate 3a, and disperses the oral pharmaceutical powder dropped from the constant quantity supply device 2 to the feeder plate 3a in a uniform thin layer or in a single layer, and guides it to the belt conveyor 4. .

Therefore, the fixed amount supply device 2 is adapted to supply a fixed amount of oral pharmaceutical powder for dispersion in the granular dispersion feeder 3 in a thin layer or in a single layer.

The belt conveyor 4 is provided at a position downstream of the feeder plate 3a in the granule dispersion feeder 3, and guides the oral pharmaceutical powder dropped from the feeder plate 3a and spread on the plane to the position of the foreign matter detecting device 20. It is a thing. In the present embodiment, the belt conveyor 4 is used as the powder / granular material conveying means, but the present invention is not necessarily limited to this, and the oral pharmaceutical powder supplied from the granule dispersion feeder 3 is conveyed to the foreign matter detection device 20. There is no particular limitation as long as it does. Therefore, for example, as shown in FIG. 2, it is also possible to use the turntable 7 as the powdery granular material conveying means. That is, turntable 7
Consists of a circular table, which allows the oral drug powder to be spread in thin layers. Furthermore, a powdery or granular material conveying means such as a vibration feeder or an electromagnetic feeder (not shown) can be used. Also by these, a commercially available product which has existed conventionally can be used.

On the other hand, as shown in FIG. 1, a defective product collecting device 5 is provided on the downstream side of the belt conveyor 4,
The defective item collecting device 5 collects the foreign substance when the foreign substance detecting device 20 detects the foreign substance. For example, when a foreign substance is found on the belt conveyor 4, the defective product collecting apparatus 5 has a defective product (not shown) which is provided on the side in advance of the direction of the powder chute 6 provided on the downstream side of the belt conveyor 4. It is designed to drop toward the storage tank. The defective product collecting device 5 is not limited to this, and may be, for example, a device that collects foreign matter by suction or the like, and may employ another collecting method.

The foreign matter detecting device 20 is provided at a substantially intermediate position of the belt conveyor 4. The foreign matter detection device 20 includes a lower illumination device 21 provided below the belt conveyor 4 and an upper illumination device 22 provided above the lower illumination device 21 with the belt conveyor 4 interposed therebetween.
And a charge coupled device (CCD) camera (hereinafter simply referred to as “CCD camera”) 23 provided on the upper side of the upper illumination device 22.

The lower illuminating device 21 and the upper illuminating device 22 as the illuminating device use a strobe or a halogen lamp (not shown) as a light source. Thus, the number of lighting devices is not limited to one, but a plurality of lighting devices can be used.

Further, the CCD camera 23 can detect foreign substances in the oral pharmaceutical powder on the belt conveyor 4 by utilizing light as a change in brightness or a change in color. That is, in the case of color, it is detected as a change in color, and in the case of black and white, a foreign substance is detected as a change in brightness.

Further, in the present embodiment, the CCD camera 2
Reference numeral 3 denotes an area sensor CCD camera capable of detecting a certain area of the oral pharmaceutical powder that is spread and conveyed on the belt conveyor 4. However, the present invention is not limited to this, and may be a line sensor CCD camera that detects the line 24, for example, as shown in FIG.

The CCD camera 23 preferably has a high resolution. Specifically, in the case of a line sensor CCD camera, those having 3000 pixels or more are preferable. In case of area sensor CCD camera, 320 × 24
It is preferably 0 pixels or more, more preferably 640
Examples include those having × 480 pixels or more. It should be noted that the CCD camera 23 may also be provided in plurality.

Further, the CCD camera 23 is connected to an analysis device (not shown), and this analysis device determines whether or not a foreign substance is present. When a foreign substance is detected, a signal is sent to the defective product collecting device 5. The powder chute 6 is sent, the direction of the powder chute 6 is changed, and the powder chute 6 is discharged to the defective storage tank.

The powder-particle inspection device 10 is, for example,
In addition, it has a metal detector or the like (not shown), and when metal is mixed as a foreign substance, the metal detector can detect the metal and the defective product collecting device 5 can collect the metal. There is.

A normal foreign matter inspection method in the foreign matter detecting device 20 will be described.

First, as shown in FIG. 1, a granular hopper 1
First, the oral pharmaceutical powder to be inspected is stored in advance.

Next, a fixed amount of the oral pharmaceutical powder contained in the granule hopper 1 is weighed by the constant quantity supply device 2 and dropped into the granule dispersion feeder 3. The oral pharmaceutical powder dropped on the granule dispersion feeder 3 is spread over a wide range by the granule dispersion feeder 3 and uniformly dispersed in a thin layer or one layer.

Next, the oral pharmaceutical powder in the granule dispersion feeder 3 drops at the starting end of the belt conveyor 4 while maintaining a thin layer or layer.

The oral drug powder uniformly placed in a thin layer or a single layer on the belt conveyor 4 passes through the foreign matter detecting device 20 in due course. At the position of the foreign matter detection device 20, the oral pharmaceutical powder is illuminated by the lower illumination device 21 and the upper illumination device 22 and becomes bright. Then, the CCD camera 23 provided on the upper side of the upper illumination device 22 determines the brightness and color of the oral pharmaceutical powder, and when a foreign substance is detected, an analysis device connected to the CCD camera 23
A signal is sent to the defective product collecting device 5 to change the direction of the powder chute 6 to discharge or suck the defective product storage tank.

When no foreign substance is detected in the oral drug powder, the oral drug powder on the belt conveyor 4 is conveyed as it is on the belt conveyor 4, and eventually the belt conveyor 4 falls from the conveying end portion to cause the powder. It is stored in a non-defective product collecting container (not shown) through the chute 6.

Here, the foreign matter detection device 20 of the present embodiment
In the above, the detection sensitivity of the CCD camera 23 may decrease due to deterioration of the light source, stains, and the like. Therefore, it is necessary to confirm whether or not the foreign matter detection device 20 can detect the foreign matter. Further, in the actual inspection of the foreign matter, it is extremely rare that the foreign matter exists, and as a result, the foreign matter detection device 20 rarely detects the foreign matter. Therefore, it is important to confirm whether or not the foreign matter detection device 20 operates normally as a quality control in the manufacturing process of the oral pharmaceutical powder.

In this respect, conventionally, foreign matter such as hair was mixed as a sample on the belt conveyor 4, and it was checked whether or not the foreign matter detection apparatus 20 can detect the foreign matter. However, in that method, it is difficult to remove only the foreign matter after detection because the foreign matter itself is small. Further, even if the mixed foreign matter sample is stored in, for example, a defective storage tank, it is difficult to find the foreign matter sample in the storage tank. Therefore, the foreign matter sample is passed through the foreign matter detection device 20 again, or the oral pharmaceutical powder of the batch is collected. All of it had to be discarded.

Therefore, in the present embodiment, in order to prevent this, in the oral drug powder conveyed by the belt conveyor 4, or on the belt conveyor 4, two transparent thin crimpable layers are used for sealing. A foreign matter sample as the foreign matter sample is placed, and the foreign matter sample is passed through the foreign matter detecting device 20 to be detected.

Then, the foreign matter sample is detected by the foreign matter detecting device 20.
The foreign matter sample is removed by the defective product collecting device 5 when it is detected by.

Foreign Material Sample 30 as the Foreign Material Sample
As shown in FIGS. 4A, 4B and 4C, is a transparent two crimpable thin films 31 and 31, and these two thin films 31.
-It consists of a foreign substance 32 sealed to 31.

The foreign substance 32 may be any solid substance other than the oral pharmaceutical powder as shown in FIG. 4 (a). That is, when it is desired to check whether the foreign matter detection device 20 is abnormal or normal, the foreign matter detection device 20, that is, a device close to the detection limit of the CCD camera 23 and larger than the detection limit is used. It Specifically, about 200 μm
To 500 μm are used. Therefore, from the viewpoint of the detection limit, it is presently preferable that the foreign matter 32 is a powder or granular material having a size of, for example, 0.1 mm or more.

The foreign material 32 may be, for example, fibers or hairs, as shown in FIG. 4 (b). In the case of fiber or hair, human hair cut into about 1 to 2 mm is used.

The color or brightness of the foreign matter 32 may be different from that of the oral pharmaceutical powder to be inspected, although it depends on the type and characteristics of the detector such as the CCD camera 23. In addition, when it is desired to check the detection limit, there is no limitation on the size, brightness, color or the like.

On the other hand, the above-mentioned thin films 31, 31 are, for example,
It may be a polygon such as a triangle, a quadrangle, ... Having a size of 5 mm to 30 mm on one side. The foreign material sample 30
This is because even if the defective product is discharged to the defective storage tank by the defective product collecting device 5, it can be easily found as long as one side is 5 mm or more. Therefore, it is possible to make the size a little smaller within a range that does not hinder the distinctiveness or the handling. On the other hand, if it is too large, it is inconvenient to handle, so it is preferably 30 mm or less. It is more preferably 20 mm or less. Also, if one side has a size of 5 mm to 30 mm, for example, by providing a mesh net as the defective product collecting device 5 immediately before entering the defective storage tank, the defective product can be easily collected. Therefore, at that time, the size can be made a little smaller depending on the mesh width of the mesh network.

The shape of the thin films 31 and 31 is not limited to the polygonal shape, as long as it can be distinguished from the oral pharmaceutical powder, and may have a similar size, for example, a circular shape or a substantially circular shape.

In forming the foreign matter sample 30 described above,
As a method for sealing with two transparent thin films 31 that can be pressure-bonded, for example, a transparent resin that can be heat-pressed or heat-sensitive adhesive can be used. That is, it is a method such as so-called laminating.

Here, the thin film 31 is made of transparent resin.
It is necessary that the foreign matter detection device 20 has a transparency that cannot be detected. Further, the thickness is preferably 10 times or less the diameter of the oral pharmaceutical powder. As the material,
From the viewpoint of transparency, polyethylene, polypropylene, polyethylene terephthalate, a copolymer with ethylene and the like can be mentioned. The transparent resin thin film 31 that can be heat-pressed or heat-sensitive adhesive may be provided on one side or both sides. In case of only one side, the other side can be thermocompression bonded,
Alternatively, a transparent resin thin film 31 capable of heat-sensitive adhesion and a normal transparent resin base material capable of pressure bonding or adhesion may be used.

As described above, according to the quality control method of the oral pharmaceutical powder of the present embodiment, it is determined whether or not the foreign substance is present in the oral pharmaceutical powder being conveyed by the belt conveyor 4, the turntable 7 or the like. In the quality control method of the oral pharmaceutical powder to be inspected by the detection device 20, two transparent particles are provided in the granular material conveyed by the belt conveyor 4 or the turntable 7 or on the belt conveyor 4 or the turntable 7. Of the foreign matter 32 sealed by the crimpable thin films 31 and 31 as the foreign matter sample 30, the step of operating the belt conveyor 4 or the turntable 7 to pass the foreign matter sample 30 through the foreign matter detection device 20, and the foreign matter sample When the foreign matter 32 of 30 is detected by the foreign matter detecting device 20, the foreign matter sample 30 is removed.

According to the above-mentioned embodiment, the foreign substance 32 is the foreign substance sample 30 sealed by the two transparent thin films 31 which can be pressure-bonded, so that it is easily separated from the oral pharmaceutical powder. It can be collected separately.

As a result, when inspecting the oral pharmaceutical powder for the presence of a foreign substance, the foreign substance 32 is used in advance for detection and confirmation.
It is possible to provide a method for quality control of an oral pharmaceutical powder capable of easily recovering the above.

Further, in the quality control method of the oral pharmaceutical powder of the present embodiment, the foreign matter 32 of the foreign matter sample 30 is fiber, hair, or has a size of 0.1 mm or more. It is possible to confirm the detection of fibers and hairs, and also to detect the foreign matter beyond the detection limit of the CCD camera 23 generally used in the foreign matter detection device 20.

Further, in the quality control method of the quality control method for powdery or granular material according to the present embodiment, since the powdery or granular material is an oral drug, it is necessary to make a detection confirmation in advance when inspecting the oral drug powder for foreign substances. It is possible to provide a quality control method for a powdery granular material that can easily collect the foreign matter 32 used.

Further, in the quality control method of the oral pharmaceutical powder according to the present embodiment, since the powder / granular material conveying means is the belt conveyor 4, the turntable 7, the vibrating feeder, or the electromagnetic feeder, the general conveying means is used. Can be used. Further, it is possible to easily secure a region where the oral pharmaceutical powder is dispersed in a plane.

In addition, in the quality control method of the oral pharmaceutical powder of the present embodiment, the foreign matter detection device 20 includes the CCD camera 2
Since 3 is provided, it becomes possible to detect a foreign substance based on the difference in brightness and color. In addition, the lower illumination device 21
Also, by providing the upper illumination device 22, it is possible to brighten the entire oral pharmaceutical powder and increase the detection sensitivity.

Moreover, in the quality control method of the oral pharmaceutical powder of this embodiment, the CCD camera 23 is a line sensor CCD camera or an area sensor CCD camera.

Therefore, when the CCD camera 23 is a line sensor CCD camera, it is possible to confirm the presence of foreign matter in the line of the oral drug powder, and therefore, for example, this can be applied to the oral drug powder moving in the conveying direction. The presence of foreign matter can be detected along the line 24 perpendicular to the transport direction.

When the CCD camera 23 is an area sensor CCD camera, the presence of foreign matter can be detected in a certain area of the oral pharmaceutical powder.

Further, in the quality control method of the oral pharmaceutical powder of the present embodiment, the lower illumination device 21 of the foreign matter detection device 20 is used.
Since the upper illumination device 22 uses a strobe or a halogen lamp as a light source, the upper illumination device 22 can be used as a suitable light source for detecting a foreign substance in the foreign substance detection device 20 including the CCD camera 23.

Further, the foreign matter sample 30 of the present embodiment
Is used in the above quality control method of oral pharmaceutical powder,
It consists of two transparent thin films 31 and 31 which can be crimped, and a foreign substance 32 sealed to these two thin films 31 and 31.

Therefore, when inspecting the oral pharmaceutical powder for the presence or absence of a foreign substance, the foreign substance 3 is used in advance for detection and confirmation.
It is possible to provide the foreign matter sample 30 that can easily collect the sample No. 2.

Further, in the foreign substance sample 30 of the present embodiment, the thin film 31 has a polygonal shape with one side having a size of 5 mm to 30 mm, or a circular shape or a substantially circular shape having a diameter of 5 mm to 30 mm. In addition, preferably 1
The side is a polygon having a size of 5 mm to 20 mm, or a circle having a diameter of 5 mm to 20 mm or a substantially circular shape.

Therefore, even if the powder is mixed in the oral drug powder, it can be easily recovered by being distinguished from the oral drug powder.

[0087]

As described above, the quality control method for powdery or granular material according to the present invention is provided with two transparent sheets in or on the powdery or granular material carrying means by the powdery or granular material carrying means. The step of placing the foreign matter sealed by the crimpable thin film as a foreign matter sample, the step of operating the powdery granular material conveying means to pass the foreign matter sample through the foreign matter detecting means, and the foreign matter of the foreign matter sample to the foreign matter detecting means. The method includes a step of removing the foreign matter sample when detected by the above method.

Therefore, since the foreign matter is a foreign matter sample sealed by two transparent thin films that can be crimped, it can be easily distinguished and collected from the granular material.

As a result, when inspecting the presence or absence of foreign matter in the powdery or granular material, it is possible to provide a quality control method for the powdery or granular material which can easily collect the foreign material sample used for detection and confirmation in advance. .

Further, the quality control method for powdery or granular material of the present invention is the method for quality control for powdery or granular material as described above, wherein the foreign material of the foreign material sample is fiber, hair or 0.1 mm.
This is a method having the above size.

Therefore, it is possible to detect and confirm fibers and hairs, and it is possible to detect foreign substances that are above the detection limit of, for example, a CCD camera generally used for foreign substance detection means.

Further, the quality control method for powdery or granular material according to the present invention is the above-mentioned quality control method for powdery or granular material, wherein the powdery or granular material is an oral pharmaceutical product.

Therefore, it is possible to provide a quality control method for powdery granules, which can easily collect a sample of foreign matter used in advance for detection confirmation when inspecting the oral pharmaceutical powdery granules for foreign matter. Play.

Further, in the quality control method for powdery or granular material according to the present invention, in the quality control method for powdery or granular material described above, the powdery or granular material conveying means is a conveyor, a turntable, a vibration feeder, or an electromagnetic feeder. .

Therefore, as the powdery or granular material conveying means, a general conveying means such as a conveyor, a turntable, a vibrating feeder, or an electromagnetic feeder can be used. Further, there is an effect that it is possible to easily secure a region in which the powdery particles are dispersed in a plane.

Further, the quality control method of the powdery or granular material of the present invention is the quality control method of the powdery or granular material as described above, wherein the foreign matter detecting means is an illuminating device and an electrically coupled device (CCD).
It is a method equipped with a camera.

Therefore, since the foreign matter detecting means is provided with the charge coupled device (CCD) camera, it is possible to detect the foreign matter based on the difference in brightness and color. Further, by providing the illumination device, it is possible to brighten the entire powdery granular material and increase the detection sensitivity.

Further, the quality control method for powdery or granular material of the present invention is the quality control method for powdery or granular material as described above, wherein the electrification coupling device camera is a line sensor electrification coupling device camera or an area sensor electrification coupling device camera. is there.

Therefore, when the electrification coupling element camera is the line sensor electrification coupling element camera, it is possible to confirm the presence of the foreign matter in the line of the granular material, so that the granular material moving in the conveying direction can be detected. The presence of foreign matter can be detected along the line perpendicular to the transport direction.

Further, when the electrically coupled device camera is an area sensor electrically coupled device camera, there is an effect that the presence of foreign matter can be detected for a certain area of the powdery or granular material.

Further, the quality control method of the powdery or granular material of the present invention is the method of quality control of the powdery or granular material as described above, wherein the illumination device of the foreign matter detecting means uses a strobe or a halogen lamp as a light source. Is.

Therefore, since the illumination device of the foreign matter detecting means uses a strobe or a halogen lamp as a light source, it is used as a suitable light source for detecting the foreign matter in the foreign matter detecting means provided with a CCD camera, for example. There is an effect that can be.

As described above, the foreign matter sample of the present invention is used in the above-described quality control method for powdery or granular material, and is sealed with two transparent thin films that can be pressure-bonded and these two thin films. It is composed of foreign matter.

Therefore, when inspecting the presence or absence of foreign matter in the powdery or granular material, it is possible to provide a foreign matter sample from which a foreign matter sample used in advance for detection and confirmation can be easily collected.

The foreign matter sample of the present invention is the foreign matter sample described above, wherein the thin film has a side of 5 mm to 30 mm.
Or a circular shape or a substantially circular shape having a diameter of 5 mm to 30 mm. In addition, it is preferable that one side has a polygonal shape having a size of 5 mm to 20 mm, or a circular shape or a substantially circular shape having a diameter of 5 mm to 20 mm.

Therefore, even if it is mixed in the powdery granular material, it can be easily distinguished from the powdery granular material and recovered.

[Brief description of drawings]

FIG. 1 is a structural diagram showing an embodiment of a powdery or granular material inspection device used in a quality control method for powdery or granular material according to the present invention.

FIG. 2 is a structural diagram showing an outline of a powdery or granular material inspection device using a turntable as the powdery or granular material conveying means.

FIG. 3 is a structural diagram showing an outline of a powdery or granular material inspection device using a line sensor CCD camera as a foreign matter detection device.

FIG. 4 (a) is a plan view showing a sample of foreign matter composed of two transparent thin films that can be crimped and granular foreign matter sealed in these two thin films, and FIG. FIG. 4C is a plan view showing a foreign substance sample composed of a thin film and a foreign substance for hair sealed with these two thin films, and FIG.

[Explanation of symbols]

1 Granule hopper 2 fixed quantity supply device 3 Granule dispersion feeder 4 Belt conveyor (powder / granular material conveying means, conveyor) 5 Defective product collection device 6 powder chute 7 Turntable (powder and granular material transportation means) 10 Powder and granular material inspection device 20 Foreign matter detection device (foreign matter detection means) 21 Lower illumination device (illumination device) 22 Upper lighting device (lighting device) 23 CCD camera 24 lines 30 Foreign matter sample (foreign matter specimen) 31 thin film 32 foreign material

   ─────────────────────────────────────────────────── ─── Continued front page    F term (reference) 2G051 AA02 AA90 AB01 AB20 AC21                       BA20 BB02 BB03 CA04 CB01                       DA01 DA06 DA13                 3F079 AD08 BA06 CA31 CA44 CB25                       CB29 CB31 CB33 CB35 CC05                       DA02 DA06 DA12 EA09 EA17

Claims (10)

[Claims] 1. A quality control method for a powder or granular material, wherein the foreign material detecting means inspects whether or not a foreign material is present in the powder or granular material being conveyed by the powder or granular material conveying means. A step of placing a foreign substance sealed by two transparent thin films that can be pressure-bonded as a foreign substance sample in or on the powdery granular substance transporting means, and operating the powdery granular substance transporting means. A quality control of the granular material, which comprises: passing the foreign matter sample through the foreign matter detecting means; and removing the foreign matter sample when the foreign matter in the foreign matter sample is detected by the foreign matter detecting means. Method. 2. The method of quality control of a granular material according to claim 1, wherein the foreign matter of the foreign matter sample is different from the brightness of the granular material or the color of the granular material. 3. The quality control method for powdery or granular material according to claim 2, wherein the foreign matter in the foreign matter sample is fiber, hair, or has a size of 0.1 mm or more. 4. The method for quality control of powdery or granular material according to claim 1, 2 or 3, wherein the powdery or granular material is an oral pharmaceutical product. 5. The quality control of the powdery or granular material according to claim 1, wherein the powdery or granular material conveying means is a conveyor, a turntable, a vibration feeder, or an electromagnetic feeder. Method. 6. The granular material according to any one of claims 1 to 5, wherein the foreign matter detecting means includes an illuminating device and a charge coupled device (CCD) camera. Quality control method. 7. The quality control method for powdery or granular material according to claim 6, wherein the electrically coupled device camera is a line sensor electrically coupled device camera or an area sensor electrically coupled device camera. 8. The quality control method for powdery or granular material according to claim 6, wherein the illumination device of the foreign matter detection means uses a strobe or a halogen lamp as a light source. 9. Use of the powdery granular material quality control method according to any one of claims 1 to 8, two transparent thin films that can be crimped, and a foreign substance sealed between these two thin films. A foreign material specimen characterized by comprising: 10. The foreign material according to claim 9, wherein the thin film is formed of a polygon having a side of 5 mm to 30 mm, or a circular shape or a substantially circular shape having a diameter of 5 mm to 30 mm. Specimen.