JP7370434B1 - Dissimilar tablet leakage risk management system, dissimilar tablet spillage risk management method, and container production system - Google Patents

Abstract

An object of the present invention is to provide a dissimilar tablet leakage risk management system that can more effectively reduce the risk of dissimilar tablet containers leaking to subsequent processes. A leakage risk management system 70 includes a risk evaluation section 752 and a risk reduction action execution section 753. When the PTP sheet is produced according to the production schedule, the risk evaluation unit 752 determines whether the tablets stored in the PTP sheet produced immediately before the next PTP sheet are mixed in as different tablets by mistake. Then, the risk of the PTP sheet containing the different types of tablets flowing out from the PTP packaging machine 10 to a subsequent process is evaluated. The risk reduction treatment execution unit 753 is enabled to execute a treatment for reducing the risk based on the evaluation result by the risk evaluation unit 752. [Selection diagram] Figure 5

Description

The present invention relates to a system and method for reducing the risk of a tablet container into which a different type of tablet is accidentally mixed flowing into a subsequent process, and a production system for containers equipped with the system.

Generally, in the fields of pharmaceuticals, foodstuffs, etc., tablet containers containing tablets are widely used. Examples of the tablet container include a blister sheet and a bottle filled with tablets. A blister sheet is composed of a container film in which a pocket portion is formed into which tablets are filled, and a cover film attached to the container film so as to seal the opening side of the pocket portion.

Moreover, the tablet container is produced by a container production device. A blister packaging machine, which is a container production device for producing blister sheets, includes, for example, a device that forms pockets in a strip-shaped container film, a device that fills tablets into the pockets, and a device that attaches a cover film to a container film. It is equipped with equipment to do this.

By the way, in general, container production equipment is capable of switching the types of tablets accommodated, and each time the type is changed, it is possible to sequentially produce tablet containers of different types containing different tablets. It is configured. When switching the type of tablet container to be produced, it is necessary to prevent tablets from the previously produced tablet container from being mistakenly mixed into the next tablet container as different types of tablets. In order to prevent this, the container production equipment is cleaned, but there is still a possibility that different types of tablets may be mixed in.

Therefore, in order to prevent tablet containers containing different types of tablets (hereinafter referred to as "different types of tablet containers") from flowing into the subsequent process of the container production device, an inspection device installed in the container production device , a method has been proposed for detecting tablets with different colors and shapes as dissimilar tablets (see, for example, Patent Document 1). Furthermore, there is also known a method of detecting different types of tablets using the area of a region related to a tablet or spectroscopic analysis (see, for example, Patent Documents 2 and 3).

Japanese Patent Application Publication No. 2015-200595 Japanese Patent Application Publication No. 2011-112527 Japanese Patent Application Publication No. 2018-179568

By the way, the lower the risk of dissimilar tablet containers leaking to subsequent processes than the container production equipment, the better. However, the above-mentioned methods are merely methods for detecting dissimilar tablets by actually inspecting the tablets. do not have. Therefore, in order to further reduce the risk of leakage in these methods, it is necessary to add a new inspection device that can perform inspections on inspection items different from the inspection items that were previously performed. However, there is a limit to reducing the risk of leakage by adding new testing equipment.

The present invention has been made in view of the above circumstances, and its purpose is to provide a dissimilar tablet leakage risk management system that can more effectively reduce the risk of dissimilar tablet containers leaking to subsequent processes. There is a particular thing.

In the following, each means suitable for solving the above object will be explained in terms of sections. Note that effects specific to the corresponding means will be added as necessary.

Means 1. Dissimilar tablet leakage risk management applied to container production equipment that is capable of switching the type of tablets accommodated and that can sequentially produce tablet containers containing different tablets each time the type is changed. A system,
schedule management means for managing a production schedule including information regarding the production order of the tablet containers by the container production device;
When the tablet accommodating bodies are produced according to the production schedule, the tablets stored in the tablet accommodating body produced immediately before the next produced tablet accommodating body are mistakenly treated as different tablets. a risk evaluation means for evaluating the risk that the tablet container containing the different types of tablets will flow out to a downstream process from the container production device;
A risk management system for dissimilar tablet leakage, comprising: a risk reduction action execution means capable of executing action for reducing the risk based on the evaluation result by the risk evaluation means.

The production schedule managed by the schedule management means may be input and stored in advance by an operator or the like, or it may be automatically derived (generated) by a schedule derivation means, as in means 6, which will be described later. It may be something that

In addition, "measures to reduce the risk" include, for example, measures to prompt changes in the production schedule using alarms, measures to present a production schedule that can further reduce the risk of leakage, and measures to change the type of tablet container. With regard to the cleaning of the container production equipment that is carried out at the time of switching, measures can be taken to encourage a longer cleaning time. Here, "measure to present a production schedule that can further reduce the risk of leakage" refers to a procedure to present one or more production schedules from among multiple production schedules stored in advance, or a procedure to automatically derive a production schedule. and presents the derived production schedule.

According to the above means 1, the risk evaluation means uses the production schedule of tablet containers to determine the risk that a tablet container containing different types of tablets (different type of tablet container) will flow to a later process than the container production device. can be evaluated. Then, based on the evaluation result by the risk evaluation means, the risk reduction action execution means can take action to reduce the risk. Since the production schedule of the tablet accommodating body is utilized in this way, the risk of dissimilar tablet accommodating bodies leaking can be more effectively reduced compared to a configuration in which dissimilar tablets are detected only by inspecting the tablets.

Normally, the container production equipment is cleaned every time the type of tablet container to be produced is changed, so the tablet container produced two or more times before the tablet container to be produced next is cleaned. There are almost no cases where tablets are accidentally mixed into the tablet container. In view of this, the risk evaluation means is designed to prevent tablets stored in a tablet container produced immediately before the tablet container produced next from being mistakenly mixed as different tablets into a tablet container produced next. Evaluate the risk that tablet containers containing different types of tablets will leak to a downstream process from the container production equipment. Therefore, it is possible to reduce the processing burden associated with risk evaluation.

Means 2. The container production device has an inspection means for determining the quality of the tablet,
The risk management system for dissimilar tablet leakage according to means 1, wherein the risk evaluation means is configured to be able to evaluate the risk based on the inspection items of the tablets by the inspection means.

According to the above means 2, the risk evaluation means is capable of evaluating the risk based on the inspection items of the tablet by the inspection means. For example, in a case where only "tablet color" is included in the inspection items of tablets by the inspection means, after producing a tablet container Aw1 containing white tablets aw1, a tablet containing red tablets br2 is produced. When producing the tablet container Br2, the white tablet aw1 can be detected as a different type of tablet by the inspection means, so the risk management means evaluates that the risk is low. On the other hand, in a case where only "tablet color" is included in the inspection items of the tablet by the inspection means, after producing the tablet container Aw1 containing the white tablet aw1, the tablet containing the white tablet bw2 is produced. When producing the tablet container Bw2, it is difficult for the inspection means to detect the tablet aw1 as a different type of tablet, so the risk management means evaluates that the risk is high. By taking into consideration the inspection items of the tablets by the inspection means in this way, the risk can be appropriately and easily evaluated.

Means 3. 2. The dissimilar tablet outflow risk management system according to means 2, wherein the inspection items include at least one of the color, shape, printing, engraving, and spectrum of the tablet.

According to the above-mentioned means 3, basically the same effects as the above-mentioned means 2 are achieved. Incidentally, in terms of performing the risk evaluation more appropriately, it is preferable that the number of inspection items is as large as possible.

Means 4. The container production device has an imaging means for imaging the tablet,
The inspection means is configured to make a quality determination regarding the tablet based on the image data obtained by the imaging means,
The image data of the tablets related to the tablet container produced immediately before the tablet container is used for the inspection means configured to inspect the tablets related to the tablet container to be produced next. and an inspection simulation execution means for executing a pass/fail judgment based on virtual dissimilar tablet image data generated by
The risk evaluation means is configured to be capable of evaluating the risk based on a quality determination result obtained when the inspection simulation execution means causes the inspection means to perform quality determination based on the virtual dissimilar tablet image data. The dissimilar tablet leakage risk management system according to means 2, characterized in that:

According to the above-mentioned means 4, the inspection simulation execution means performs a pass/fail judgment using the virtual dissimilar tablet image data on the inspection means configured to inspect the tablets related to the tablet container to be produced next. You can make it happen. The risk evaluation means can evaluate the risk based on the pass/fail determination result obtained when the inspection simulation execution means causes the inspection means to perform the pass/fail determination using the virtual dissimilar tablet image data. Therefore, without actually performing a pass/fail judgment on tablets by the test means, it is confirmed in advance whether or not a different type of tablet is appropriately detected (a different type of tablet is determined to be defective) as a result of the pass/fail judgment by the test means. be able to. Thereby, the risk can be evaluated more appropriately.

Means 5. The tablet container is a blister sheet in which tablets are stored in pockets formed in a container film,
The risk evaluation means is capable of evaluating the risk based on the size of the pocket portion of the blister sheet to be produced next and the size of the tablet accommodated in the blister sheet to be produced immediately before the blister sheet. The dissimilar tablet leakage risk management system according to means 1, characterized in that the system is configured to:

According to the above means 5, the risk evaluation means is based on the size of the pocket portion in the next blister sheet to be produced (hereinafter simply referred to as "pocket size") and the blister sheet to be produced immediately before this blister sheet. The risk can be evaluated based on the size of the tablet (hereinafter simply referred to as "tablet size"). For example, if the pocket size is smaller than the tablet size, it is physically impossible to accommodate the tablets of the immediately preceding blister sheet into the pockets of the next blister sheet. , the risk evaluation means evaluates that the risk is low. On the other hand, for example, if the pocket size is larger than the tablet size, it is possible to accommodate the tablets of the blister sheet produced immediately before in the pocket of the blister sheet produced next, reducing the risk. The evaluation means evaluates that the risk is high. Therefore, according to the above means 5, the risk can be evaluated more appropriately.

Further, according to the above means 5, since the risk is evaluated based on the size of the pocket part and the tablet, the risk can be evaluated even if the container production apparatus is not equipped with an inspection means. Based on the evaluation results, measures can be taken to reduce the risk.

Means 6. The means for generating a plurality of provisional schedules including information regarding the production order of the tablet containers based on information about the plurality of tablet containers to be produced, and the risk evaluation means when the tablet containers are produced according to the tentative schedule. comprising a schedule deriving means configured to be able to derive at least the production schedule that can most reduce the risk from among the plurality of provisional schedules based on the evaluation result by;
According to means 1, the risk reduction action execution means is configured to be able to execute a action using the production schedule derived by the schedule derivation means as the action for reducing the risk. Dissimilar tablet risk management system.

According to the above means 6, the schedule derivation means can automatically derive a production schedule with a low risk of leakage, and the risk reduction action execution means can perform measures (for example, derivation) using the derived production schedule. (e.g. presentation of production schedules). Therefore, the risk can be further reduced. Furthermore, since it is no longer necessary for an operator or the like to create a production schedule, convenience can be improved.

Means 7. The dissimilar tablet leakage risk management system described in Means 1;
A container production system comprising the container production device.

According to the above-mentioned means 7, the same effect as the above-mentioned means 1 can be achieved.

Means 8. Dissimilar tablet leakage risk management applied to container production equipment that is capable of switching the type of tablets accommodated and that can sequentially produce tablet containers containing different tablets each time the type is changed. A method,
When the tablet containers are produced according to a production schedule including information regarding the production order of the tablet containers by the container production device, for the next tablet container to be produced, the tablet container is produced immediately before the tablet container is produced. A risk assessment for evaluating the risk that tablets accommodated in the tablet accommodating body are mistakenly mixed as different tablets, and the tablet accommodating body mixed with the dissimilar tablets flows out to a downstream process from the accommodating body production device. process and
A method for managing the risk of outflow of different types of tablets, comprising: a risk reduction treatment execution step of executing treatment to reduce the risk based on the evaluation result of the risk evaluation step.

According to the above-mentioned means 8, the same effects as the above-mentioned means 1 can be achieved.

Note that the technical matters related to each of the above means may be combined as appropriate. For example, the technical matter related to the above-mentioned means 2 or 3 may be combined with at least one of the technical matters related to the above-mentioned means 4 to 6. Furthermore, for example, the technical matter concerning means 7 or 8 may be combined with at least one of the technical matters concerning means 1 to 6 above.

It is a perspective view showing a PTP sheet. It is a partially enlarged sectional view of a PTP sheet. It is a top view showing a PTP sheet. It is a perspective view showing a PTP film. FIG. 1 is a block diagram showing a schematic configuration of a container production system. FIG. 1 is a schematic diagram showing a schematic configuration of a PTP packaging machine. FIG. 2 is a block diagram showing the electrical configuration of the inspection device. It is a schematic diagram showing the schematic structure of the inspection camera in the third inspection device. It is a table showing the inspection items of tablets performed by each inspection device. It is a table diagram showing various data stored in the test data management device. It is a table diagram showing an example of shape data, etc. It is a table diagram showing another example of shape data, etc. FIG. 2 is a schematic diagram showing an example of information displayed on a display device. It is a flowchart of inspection simulation processing. It is an explanatory diagram for explaining the risk score when switching from type K1 to type K2. It is an explanatory diagram for explaining the risk score when switching from type K2 to type K3.

Hereinafter, one embodiment will be described with reference to the drawings. First, the structure of the PTP sheet will be explained.

As shown in FIGS. 1 and 2, the PTP sheet 1 includes a container film 3 having a plurality of pockets 2, and a cover film 4 attached to the container film 3 so as to close the pockets 2. ing. In this embodiment, the PTP sheet 1 corresponds to a "tablet package" and a "blister sheet."

The container film 3 is made of a transparent or translucent thermoplastic resin material such as PP (polypropylene) or PVC (polyvinyl chloride). On the other hand, the cover film 4 is made of an opaque material (for example, aluminum foil, etc.) on the surface of which a sealant made of, for example, polypropylene resin or the like is provided. Of course, the materials for each of the films 3 and 4 are not limited to these, and other materials may be used.

The PTP sheet 1 is manufactured by punching a belt-shaped PTP film 6 (see FIG. 4) formed from a belt-shaped container film 3 and a belt-shaped cover film 4 into a sheet shape, and has a substantially rectangular shape in plan view. formed into a shape.

Further, the PTP sheet 1 has two rows of pockets in its transverse direction, each consisting of five pockets 2 arranged along its longitudinal direction. That is, a total of ten pocket portions 2 are formed. Further, each pocket portion 2 accommodates one tablet 5. The tablet 5 is visible through the pocket 2 when viewed from the front side of the PTP sheet 1 (the protruding side of the pocket 2).

The tablet 5 is a disc-shaped uncoated tablet having a circular shape in a plan view, and has a side surface 5a, and a front surface 5b and a back surface 5c sandwiching the side surface 5a. A printing section 5k (see FIG. 3) on which characters, symbols, numbers, figures, etc. indicating product information regarding the tablet 5 are printed is provided on the front surface 5b and the back surface 5c. Product information regarding the tablet 5 may include "product name," "content," "dosage form," "manufacturer," and "lot number."

In addition, the structure of the PTP sheet 1 mentioned above is an example to the last, and the structure of the PTP sheet 1 can be changed suitably. Therefore, for example, the number and shape of the pocket portions 2, and the type of tablets 5 accommodated in the pocket portions 2 (color, shape, presence or absence of the printed portion 5k, ingredients, etc.) may be changed as appropriate.

Next, with reference to FIG. 5 and the like, the PTP packaging machine 10 for manufacturing the PTP sheet 1 and the dissimilar tablet spillage risk management system 70 (hereinafter simply referred to as "spillage risk management system") applied to the PTP packaging machine 10 will be described. 70'') will be described. In this embodiment, the PTP packaging machine 10 constitutes a "container production device." First, the PTP packaging machine 10 will be explained.

The PTP packaging machine 10 is capable of switching the type of tablets 5 accommodated in the pocket portion 2, and is also capable of sequentially producing PTP sheets 1 containing different tablets 5 each time the type is changed. It is a device. However, when changing the type of tablet 5 and the type of PTP sheet 1 to be manufactured, the PTP packaging machine 10 must be cleaned and parts (for example, components of the pocket forming device 16 described later). exchange etc. will be carried out.

As shown in FIG. 6, on the most upstream side of the PTP packaging machine 10, the original fabric of the strip-shaped container film 3 is wound into a roll. The drawn-out end side of the container film 3 wound into a roll is guided by guide rolls 11 and 12. The container film 3 is hung on an intermittent feed roll 13 on the downstream side of the guide rolls 11 and 12. The intermittent feed roll 13 is connected to a motor that rotates intermittently, and conveys the container film 3 intermittently.

Between the guide roll 12 and the intermittent feed roll 13, a heating device 15 and a pocket forming device 16 are arranged in this order along the conveyance path of the container film 3. Then, in a state where the container film 3 is heated by the heating device 15 and becomes relatively flexible, a plurality of pocket portions 2 are formed at predetermined positions of the container film 3 by the pocket portion forming device 16. The pocket portion 2 is formed during an interval between the conveyance operations of the container film 3 by the intermittent feed roll 13.

The container film 3 sent out from the intermittent feed roll 13 is hung around a guide roll 17, a tension roll 18, and a film receiving roll 20 in this order. Since the film receiving roll 20 is connected to a motor that rotates at a constant rate, it conveys the container film 3 continuously at a constant speed. The tension roll 18 is in a state in which the container film 3 is pulled to the tension side by elastic force, and prevents the container film 3 from loosening due to the difference in conveyance operation between the intermittent feed roll 13 and the film receiving roll 20, and tightens the container film 3. The film 3 is kept under tension at all times.

Upstream of the film receiving roll 20, a filling device 21, a first inspection device 22, a second inspection device 23, and a third inspection device 24 are arranged in this order along the conveyance path of the container film 3. In this embodiment, the first inspection device 22, the second inspection device 23, and the third inspection device 24 each constitute an "inspection means."

The filling device 21 includes, for example, a cylindrical chute for accommodating the tablets 5 in a line, and a shutter (not shown) that can open and close the outlet of the chute. By opening the shutter, the pocket portion 2 is filled with tablets 5 (accommodated).

The first inspection device 22, the second inspection device 23, and the third inspection device 24 each perform quality determination regarding at least the tablet 5. More detailed configurations of the inspection devices 22 to 24 will be described later.

On the other hand, the original fabric of the cover film 4 formed into a band shape is wound into a roll shape on the most upstream side. The drawn-out end of the cover film 4 wound into a roll is guided toward a heating roll 26 by a guide roll 25.

The heating roll 26 can be brought into pressure contact with the film receiving roll 20, so that the container film 3 and the cover film 4 are fed between both rolls 20 and 26. Then, by passing both the films 3 and 4 between the rolls 20 and 26 in a heat-pressed state, both the films 3 and 4 are attached, and the pocket portion 2 is closed with the cover film 4. As a result, a strip-shaped PTP film 6 in which a tablet 5 is housed in each pocket portion 2 is manufactured.

The PTP film 6 sent out from the film receiving roll 20 is hung on a tension roll 27 and an intermittent feed roll 28 in this order. Since the intermittent feed roll 28 is connected to a motor that rotates intermittently, the PTP film 6 is intermittently conveyed. The tension roll 27 is in a state in which the PTP film 6 is pulled to the tension side by elastic force, and prevents the PTP film 6 from loosening due to the difference in conveyance operation between the film receiving roll 20 and the intermittent feed roll 28, and thereby The film 6 is kept under tension at all times.

The PTP film 6 sent out from the intermittent feed roll 28 is hung on a tension roll 31 and an intermittent feed roll 32 in this order. Since the intermittent feed roll 32 is connected to a motor that rotates intermittently, the PTP film 6 is intermittently conveyed. The tension roll 31 is in a state where the PTP film 6 is pulled toward the tension side by elastic force, and prevents the PTP film 6 from loosening between the intermittent feed rolls 28 and 32.

Between the intermittent feed roll 28 and the tension roll 31, a slit forming device 33 and a marking device 34 are arranged in this order along the conveyance path of the PTP film 6. The slit forming device 33 has a function of forming a separation slit at a predetermined position of the PTP film 6. The marking device 34 has a function of marking a predetermined position on the PTP film 6. Note that in FIG. 1 and the like, illustrations of the separation slit and the markings are omitted.

The PTP film 6 sent out from the intermittent feed roll 32 is hung on a tension roll 35 and a continuous feed roll 36 in that order on the downstream side thereof. A sheet punching device 37 is disposed between the intermittent feed roll 32 and the tension roll 35 along the conveyance path of the PTP film 6. The sheet punching device 37 punches out the outer edges of the PTP film 6 in units of PTP sheets. Thereby, the PTP sheet 1 is obtained.

The obtained PTP sheet 1 is conveyed by a conveyor 39 and temporarily stored in a hopper 40 for finished products. However, the PTP sheet 1 containing the tablet 5 that has been determined to be defective by at least one of the inspection devices 22, 23, and 24 is not sent to the finished product hopper 40, but is instead sent to the finished product hopper 40 by a defective sheet discharge mechanism (not shown). It is discharged separately.

A cutting device 41 is disposed downstream of the continuous feed roll 36. Then, the unnecessary film portion 42 constituting the band-shaped residual material portion (scrap portion) remaining after punching by the sheet punching device 37 is guided by the tension roll 35 and the continuous feed roll 36, and then guided to the cutting device 41. . The cutting device 41 cuts the unnecessary film portion 42 into predetermined dimensions. The cut unnecessary film portion 42 (scrap) is stored in a scrap hopper 43 and then disposed of separately.

Next, a more specific configuration of the inspection devices 22 to 24 will be described with reference to FIG. 7. Each of the inspection devices 22 to 24 includes a lighting device 50, an inspection camera 51, and a quality determining device 52, respectively. In this embodiment, the inspection camera 51 constitutes an "imaging means".

The illumination device 50 irradiates the container film 3 and the tablet 5 with predetermined light (for example, near-infrared light or visible light) from the opening side or the protrusion side of the pocket part 2. The illumination device 50 of the third inspection device 24 is capable of irradiating near-infrared light, and irradiates a predetermined region of the container film 3 with near-infrared light from diagonally above. As the illumination device 50 of the third inspection device 24, for example, a halogen lamp capable of emitting near-infrared light having a continuous spectrum (for example, in a near-infrared region with a wavelength of 700 to 2500 nm) can be employed. Note that as a light source other than a halogen lamp, a deuterium discharge tube, a tungsten lamp, a xenon lamp, etc. can be used.

The inspection camera 51 images the container film 3 and the tablet 5. In this embodiment, the inspection camera 51 is a CCD camera that is sensitive to the wavelength range of the light emitted from the illumination device 50. Further, as the inspection camera 51 of the second inspection device 23, a color CCD camera is employed so that color discrimination is possible. Note that a CMOS camera may be used instead of the CCD camera. In this embodiment, the inspection camera 51 of the first inspection device 22 obtains luminance image data, and the inspection camera 51 of the second inspection device 23 obtains color image data.

In addition, the inspection camera 51 of the third inspection device 24 is for obtaining spectral image data related to the tablet 5, and is equipped with an optical lens 511, a two-dimensional spectrometer 512, and an image sensor 513 (FIG. 8 reference).

The optical lens 511 is composed of a plurality of lenses (not shown) and is configured to be able to convert incident light into parallel light. The optical lens 511 has its optical axis set along the vertical direction. Further, the optical lens 511 is configured to be able to image incident light onto a position of a slit 512a of the two-dimensional spectrometer 512, which will be described later.

The two-dimensional spectrometer 512 includes a slit 512a, an entrance lens 512b, a spectroscopic section 512c, and an exit lens 512d. The spectroscopic section 512c includes an entrance side prism 512ca, a transmission type diffraction grating 512cb, and an output side prism 512cc.

The slit 512a is formed between a pair of substantially flat slit plates 514. The slit 512a has an elongated substantially rectangular (linear) opening, and its width direction (short side direction) is arranged along the conveyance direction of the container film 3, and its longitudinal direction is a direction perpendicular to the conveyance direction. It is located along the

Under such a configuration, the light passing through the slit 512a is collimated by the entrance lens 512b, then separated into spectra by the spectrometer 512c, and a two-dimensional spectral image (spectral spectrum) is displayed on the image sensor 513 by the exit lens 512d. imaged as.

The image sensor 513 has a light receiving surface 513a in which a plurality of light receiving elements (pixels) 515 are two-dimensionally arranged. As the image sensor 513, a CCD area sensor having sufficient sensitivity to a wavelength range of, for example, 900 to 1700 nm in the near-infrared region can be employed. Of course, the image sensor is not limited to this, and other sensors having sensitivity in the near-infrared region (for example, a CMOS sensor, an MCT (HgCdTe) sensor, etc.) may be used.

The spectrum (wavelength component light) of the reflected light reflected by the container film 3 and the tablet 5 is received by each light receiving element (each pixel) 515 of the image sensor 513. Then, spectral image data corresponding to the intensity of the received light is input to the quality determining device 52.

The image data (luminance image data, color image data, spectral image data) obtained by imaging with the inspection camera 51 is converted into a digital signal inside the inspection camera 51, and is then judged as a quality signal in the form of a digital signal. It is input to the determination device 52.

The quality determination device 52 includes a CPU as a calculation means, a ROM for storing various programs, a RAM for temporarily storing various data such as calculation data and input/output data, and a storage medium for long-term storage of various data. , which is configured as a so-called computer system. The quality determination device 52 includes an image memory 53, an inspection result storage device 54, a determination memory 55, an inspection condition storage device 56, a camera timing control device 57, and a CPU and an input/output interface 58.

The image memory 53 stores image data obtained by the inspection camera 51. In addition, in the quality determination device 52, spectral data is generated based on the spectral image data, and the spectral data is sequentially stored in the image memory 53 in chronological order. As a result, two-dimensional image data (spectral image data) having spectral data for each pixel is obtained. Then, an inspection is performed based on the image data (luminance image data, color image data, spectral image data) stored in the image memory 53. Of course, processing processing (for example, binarization processing, etc.) may be performed on the image data when performing the inspection. Note that the processed image data is also stored in the image memory 53.

The test result storage device 54 stores data on pass/fail determination results, statistical data obtained by probabilistically processing the data, and the like.

The determination memory 55 is for storing various information used for determination. Various types of information include criteria for determining pass/fail (for example, threshold values, etc.), threshold values for binarization for performing binarization processing, and data for defining the inspection target range (for example, tablets in image data). (information for identifying the 5 parts, etc.).

Information corresponding to the type of tablet 5 to be inspected is input to the determination memory 55 from an inspection data management device 74, which will be described later. Therefore, the determination memory 55 stores at least information (inspection condition data) necessary for determining the quality of the tablet 5 to be inspected. The information stored in the determination memory 55 can be changed, added to, and deleted by the test data management device 74.

The inspection condition storage device 56 stores the date and time of defect determination, inspection conditions used in the inspection, and the like.

The camera timing control device 57 controls the imaging timing of the inspection camera 51. Such imaging timing is controlled based on a signal from an encoder (not shown) provided in the PTP packaging machine 10, and imaging is performed by the inspection camera 51 every time the container film 3 is fed by a predetermined amount.

The CPU and input/output interface 58 are in charge of various controls in the inspection devices 22-24. The CPU and the input/output interface 58 are capable of transmitting and receiving information to and from the constituent devices of the PTP packaging machine 10. This makes it possible to control the above-mentioned defective sheet ejection mechanism and the like. Further, the CPU and input/output interface 58 are capable of transmitting and receiving information to and from the leakage risk management system 70.

The quality determination device 52 configured as described above executes quality determination of at least the tablet 5 based on the image data obtained by the inspection camera 51. The quality determining device 52 performs, for example, binarization processing on the image data and block processing on the binary image data, and also determines the quality of the tablet 5 or the like based on various information stored in the determination memory 55.

Next, the inspection items performed by each of the inspection devices 22 to 24 will be explained in more detail.

The first inspection device 22 determines the quality of the tablet 5 based on the image data (luminance image data) obtained by the inspection camera 51 with respect to the inspection item "shape of the tablet" (see FIG. 9). In the quality determination regarding the "shape of the tablet 5", determination is made as to whether the tablet 5 is cracked or chipped, and whether the shape and size of the tablet 5 are compatible with the manufactured product type.

Based on the image data (color image data) obtained by the inspection camera 51, the second inspection device 23 inspects the above-mentioned "shape of the tablet" as well as the "aspect of the printing part" and the "color of the tablet." The quality of the tablet 5 is determined for each item (see FIG. 9). In the quality determination regarding the "aspect of the printing section," the presence or absence of the printing section 5k, the shape and color of the printing section 5k, etc. are determined. In addition, when providing a stamp on the tablet 5, in the quality determination regarding the "aspect of the printing part", the quality determination regarding the aspect of the stamp may also be performed. In the quality determination regarding "tablet color", it is determined whether the color of the tablet 5 matches the manufactured product type.

The third inspection device 24 determines the quality of the tablet 5 based on the image data (spectral image data) obtained by the inspection camera 51 with respect to the inspection item "spectrum of the tablet" (see FIG. 9). In the quality determination regarding the "tablet spectrum", principal component analysis (PCA) is performed on the spectrum image data obtained by the inspection camera 51 to determine whether the components of the tablet 5 are compatible with the manufactured product type. be done.

If all of the above-mentioned inspection items regarding the tablet 5 are determined to be good, the tablet 5 is determined to be good, and if at least one of the inspection items is determined to be defective, the tablet 5 is determined to be good. It is determined that the product is defective. If the tablet 5 is determined to be a defective product, the PTP sheet 1 containing the defective tablet 5 is discharged as a defective product by the defective sheet discharging mechanism.

Next, the leakage risk management system 70 will be explained. The leakage risk management system 70 evaluates the risk of storing inappropriate tablets 5 (different types of tablets) that should not originally be stored in the PTP sheet 1 based on the schedule when PTP sheets 1 of different types are manufactured one after another. At the same time, based on that evaluation, measures are taken to reduce risks.

As shown in FIG. 5, the leakage risk management system 70 includes a display device 71, an input device 72, a schedule management device 73, an examination data management device 74, and a processing device 75. In this embodiment, the schedule management device 73 constitutes a "schedule management means." The schedule management device 73, the test data management device 74, and the processing device 75 are configured by a computer system or the like including a CPU, ROM, RAM, storage medium, and the like.

The display device 71 displays information stored in the leakage risk management system 70. In this embodiment, the display device 71 displays a production schedule (input schedule) input by an operator or the like, and a production schedule (proposed schedule) presented by a risk reduction action execution unit 753 (described later) (see FIG. 13). ). The display device 71 also displays a production schedule (derived schedule) derived by a schedule deriving unit 731 (described later), a production schedule (determined Schedule) etc. are also displayed. However, the information displayed on the display device 71 can be changed as appropriate. Furthermore, as will be described later, when the production schedule deriving function by the schedule deriving unit 731 is disabled, the derived schedule may not be displayed.

The input device 72 is used to input information to the spill risk management system 70. An operator or the like can use the input device 72 to input the type of PTP sheet 1 to be produced and the production schedule. Further, the operator or the like can select and determine the final production schedule (to be used in actual production) from among the proposed schedules using the input device 72. The input information is stored in the schedule management device 73.

The schedule management device 73 manages a production schedule including information regarding the production order of the PTP sheets 1 by the PTP packaging machine 10. In this embodiment, the schedule management device 73 has a function of storing various production schedules such as the above-mentioned input schedule and derived schedule, and the type of PTP sheet 1 to be produced. A production schedule (input schedule) input by an operator or the like is stored in the schedule management device 73 after being associated with a priority order set by the operator or the like. For example, when producing PTP sheets 1 of types K1, K2, or K3 (see FIG. 10, etc.) in which different tablets 5 are housed, an operator etc. may select "K1→K2→K3" or "K2 →K1→K3", "K1→K3→K2", and other production schedules are input. As a result, for example, the first priority production schedule is "K1 → K2 → K3", the second priority production schedule is "K2 → K1 → K3", and the third priority production schedule is "K1 → K3 → K2". ” are respectively stored in the schedule management device 73.

Furthermore, the schedule management device 73 in this embodiment includes a schedule derivation section 731. In this embodiment, the schedule deriving unit 731 constitutes a "schedule deriving means". The schedule derivation unit 731 performs a process of automatically deriving a production schedule (schedule derivation process) using information regarding the type of PTP sheet 1 to be produced.

More specifically, the schedule management device 73 generates a plurality of provisional schedules including information regarding the production order of these PTP sheets 1 based on the types of PTP sheets 1 to be produced that are input by an operator or the like. For example, assume that the schedule management device 73 stores types K1, K2, and K3 as the types of PTP sheets 1 scheduled to be produced. In this case, the schedule derivation unit 731 outputs "K1→K2→K3", "K1→K3→K2", "K2→K1→K3", "K2→K3→K1", "K3→K1→K2", " A total of six types of tentative schedules such as "K3→K2→K1" are generated.

Then, the schedule deriving unit 731 selects at least the following "risks" from among the plurality of tentative schedules based on the evaluation results by the risk evaluation section 752 (described later) when the PTP sheet 1 is produced according to these tentative schedules. Determine the production schedule that allows for the greatest reduction in The derived production schedule is stored in the schedule management device 73.

Here, the "risk" is that the tablet 5 accommodated in the PTP sheet 1 produced immediately before the next PTP sheet 1 is mistakenly mixed as a different type of tablet. This refers to the risk that the PTP sheet 1 containing different types of tablets will flow out from the PTP packaging machine 10 to a subsequent process.

In this embodiment, as will be described later, while the risk evaluation section 752 calculates a total risk score as a comprehensive evaluation of "risk," the schedule derivation section 731 calculates a total risk score as a comprehensive evaluation of "risk". (input of a request), the schedule with the minimum total risk score is derived from among the plurality of provisional schedules as the production schedule that can reduce the "risk" the most.

For example, if the tablets 5 related to varieties K1 to K3 each have a shape represented by shape data etc. as shown in FIG. If the tentative schedule is "K3", the score will be 40 points, and if the tentative schedule is "K1→K3→K2", the score will be 10 points. Note that the method for calculating the total risk score will be described later. Further, the total risk score is 30 points when the tentative schedule is "K2→K1→K3", and 10 points when the tentative schedule is "K2→K3→K1". Further, if the tentative schedule is "K3→K1→K2", the score will be 30 points, and if the tentative schedule is "K3→K2→K1", the score will be 20 points. Therefore, the schedule deriving unit 731 derives "K1→K3→K2" and "K2→K3→K1" from among the plurality of provisional schedules as production schedules that can most reduce "risk."

In addition to the production schedule with the minimum total risk score, the schedule derivation unit 731 may derive a production schedule with the total risk score lower than a predetermined value.

Furthermore, in the present embodiment, the production schedule deriving function of the schedule deriving unit 731 can be switched between enabled and disabled by an operation by an operator or the like. If the production schedule derivation function is enabled, the production schedule (input schedule) input by the operator etc. is displayed on the display device 71, as well as the production schedule (derived schedule) derived by the schedule derivation unit 731 (see FIG. (see 13). On the other hand, if the production schedule derivation function is disabled, the schedule derivation unit 731 does not derive the production schedule, and only the production schedule input by the operator or the like is displayed on the display device 71.

The test data management device 74 manages test condition data used to determine the quality of the tablet 5. The inspection data management device 74 stores inspection condition data necessary for each inspection device 22 to 24 to make a pass/fail determination. In this embodiment, the inspection condition data includes data IF1, IF2...IFn regarding the shape of the tablet 5, data IM1, IM2...IMn regarding the printing part 5k, data IC1, IC2...ICn regarding the color of the tablet 5, and data regarding the spectrum of the tablet 5. Data IS1, IS2, . . . ISn (see FIG. 10), etc. are stored. Note that data IF1, IM1, IC1, and IS1 are used to determine the quality of tablets 5 of type K1, and data IF2, IM2, IC2, and IS2 are used to determine quality of tablets 5 of type K2. are respectively used to determine the quality of tablet 5 related to variety K3.

In addition, the inspection data management device 74 outputs necessary data of the inspection condition data to each of the inspection devices 22 to 24 in accordance with the type change of the PTP sheet 1. For example, when producing the PTP sheet 1 of type K1, the first inspection device 22 makes a pass/fail judgment regarding the inspection item "shape of the tablet", so the data IF1 regarding the shape of the tablet 5 is the first It is output to the inspection device 22. In each of the inspection devices 22 to 24, settings are made in accordance with the type of PTP sheet 1 to be produced, based on inspection condition data input from the inspection data management device 74.

Furthermore, the inspection data management device 74 stores tablet image data TP1, TP2...TPn and base data PP1, PP2...PPn for each product type K1 to Kn (see FIG. 10). In this embodiment, the tablet image data TP1 to TPn are image data of the tablet 5. The base data PP1 to PPn are image data showing the container film 3 (including the pocket part 2) in a state where the tablet 5 is not accommodated in the pocket part 2. Note that the base data PP1 to PPn may be image data showing the container film 3 with the tablet 5 accommodated in the pocket portion 2. Base data PP1 to PPn and tablet image data TP1 to TPn correspond to multiple types of image data (luminance image data, color image data, spectral image data) acquired by each inspection camera 51 of inspection devices 22 to 24. Each thing you do is memorized. For example, the base data PP1 includes a total of three types of image data related to the product type K1.

Furthermore, the inspection data management device 74 stores data regarding the tablets 5 and pocket portions 2 related to the types K1, K2, . . . , Kn of the PTP sheet 1 to be produced. The data regarding the tablet 5 includes shape data TS1, TS2...TSn, print data TM1, TM2...TMn, color data TC1, TC2...TCn, and spectrum data SP1, SP2...SPn. Further, the data regarding the pocket portion 2 includes shape data PS1, PS2, . . . PSn.

As shown in FIG. 11, in this embodiment, shape data TS1 indicates that the shape is circular in plan view and has an outer diameter of 4 mm, and shape data TS2 indicates that it is circular in plan view and has an outer diameter of 6.5 mm. The shape data TS3 indicates that the shape is circular in plan view and the outer diameter is 9 mm. The shape data of the tablet 5 may include information regarding the thickness of the tablet 5, the score line, etc., for example.

The print data TM1 indicates that the printing section 5k is provided on both sides (the front surface 5b and the back surface 5c) of the tablet 5, and the print content is data A, and the print data TM2 indicates that the printing section 5k is provided on one side of the tablet 5 (the front surface 5c). 5b or the back side 5c), and indicates that the print content is data B, and print data TM3 indicates that the printing section 5k is not provided.

Color data TC1 and TC2 indicate that tablet 5 is white, and color data TC3 indicates that tablet 5 is red.

Spectral data SP1 and SP2 indicate that the spectral data obtained when the tablet 5 is spectrally analyzed is data Y, and spectral data SP3 indicates that the spectral data obtained when the tablet 5 is spectrally analyzed is data Z. Show that.

Shape data PS1 of the pocket portion 2 indicates that it is circular in plan view and has an outer diameter (especially the outer diameter of the opening) of 5.5 mm, and shape data PS2 indicates that it is circular in plan view and has an outer diameter of 8 mm. The shape data PS3 indicates that the shape is circular in plan view and the outer diameter is 10.5 mm. Note that the shape data of the pocket portion 2 may include, for example, the depth of the pocket portion 2.

The processing device 75 evaluates the "risk" of the PTP sheet 1 containing different types of tablets flowing out from the PTP packaging machine 10 to a subsequent process, and based on the evaluation result, executes measures to reduce the "risk". .

As shown in FIG. 5, the processing device 75 includes an inspection simulation execution section 751, a risk evaluation section 752, and a risk reduction treatment execution section 753. In this embodiment, the inspection simulation execution section 751 constitutes an "inspection simulation execution means", similarly, the risk evaluation section 752 constitutes a "risk evaluation means", and the risk reduction treatment execution section 753 constitutes a "risk reduction treatment execution means". , respectively.

The inspection simulation execution unit 751 sends the inspection devices 22 to 24 configured to inspect the tablets 5 related to the PTP sheet 1 to be produced next to the PTP sheet 1 to be produced immediately before the PTP sheet 1 to be produced. The quality determination is executed based on virtual dissimilar tablet image data generated using the image data of the tablet 5 related to the above. That is, when the PTP sheet 1 is produced according to the production schedule or the tentative schedule, the inspection simulation execution unit 751 uses the inspection devices 22 to 24 to detect a different type of tablet (the tablet 5 related to the PTP sheet 1 produced immediately before). This is a simulated test to confirm whether or not it is possible. Specifically, the inspection simulation execution unit 751 performs the following inspection simulation process (inspection simulation execution step) to confirm the detection of different types of tablets.

As shown in FIG. 14, in the inspection simulation process, first, in step S11, virtual dissimilar tablet image data is generated. The virtual heterogeneous tablet image data is generated using the base data PP1 to PPn related to the PTP sheet 1 to be produced next and the tablet image data TP1 to TPn of the tablet 5 related to the PTP sheet 1 to be produced immediately before. .

More specifically, by pasting the tablet image data TP1, TP2...TPn to the pocket part 2 area in the base data PP1, PP2...PPn, virtual different tablet image data is generated. For example, in an inspection simulation process for producing type K2 following type K1, virtual dissimilar tablet image data is generated by pasting tablet image data TP1 to pocket part 2 area in base data PP2. . As the virtual heterogeneous tablet image data, data assuming inspection by the first inspection device 22, data assuming inspection by the second inspection device 23, and data assuming inspection by the third inspection device 24 are generated, respectively. Ru. Note that, depending on the size of the pocket part 2 area in the base data, the tablet image data may protrude from the pocket part 2 area in the virtual dissimilar tablet image data.

Furthermore, when using image data of the tablet 5 accommodated in the pocket section 2 as the base data, virtual dissimilar tablet image data can be generated by pasting the tablet image data to the tablet 5 area in the base data. can. However, if the tablet 5 area in the base data protrudes from the pasted tablet image data, processing must be performed to erase the protruding part and bring the area corresponding to the background of the tablet image data into a natural state. is preferred. Such processing includes processing that changes the brightness value of the pixels forming the protruding area to the same value or approximate value as the brightness value of pixels located around the protruding area, and Examples include processing to expand the area.

Next, in step S12, an inspection program is executed. By executing this program, first, necessary test condition data is output from the test data management device 74 to each of the test devices 22 to 24. Further, in the inspection devices 22 to 24, settings are made for inspecting the tablets 5 related to the PTP sheet 1 to be produced next, using the input inspection condition data.

Further, by executing the inspection program, virtual dissimilar tablet image data is input to each of the inspection devices 22 to 24. For example, virtual heterogeneous tablet image data that is assumed to be inspected by the first inspection device 22 is input to the first inspection device 22 .

Then, each of the inspection devices 22 to 24 performs a quality determination based on the virtual dissimilar tablet image data. This quality determination is performed for each inspection item. The inspection simulation execution unit 751 receives the pass/fail determination results for each inspection item from the inspection devices 22 to 24.

Next, in step S13, it is determined for each inspection item whether the received quality determination result is good. If a negative determination is made in step S13, that is, if all of the different types of tablets (attached tablet image data) are determined to be defective in a certain inspection item, the inspection simulation execution unit 751 performs the The final judgment result regarding the inspection item is set as "detectable", and the inspection simulation process ends. On the other hand, if an affirmative determination is made in step S13, that is, if at least one of the different types of tablets is determined to be non-defective in a certain inspection item, the inspection simulation execution unit 751 performs the risk avoidance process in step S14 as necessary. I do.

In the risk avoidance process, the test condition data (for example, threshold value, etc.) regarding the relevant test item stored in the test data management device 74 is changed, and then the test program (step S12) is executed again. That is, after changing the test condition data so that the test accuracy is higher, for example, the test devices 22 to 24 are caused to perform pass/fail judgment for the corresponding test item using the test condition data. Note that when the actual tablets 5 are inspected by the inspection devices 22 to 24, the changeable range of the inspection condition data is predetermined in order to prevent an excessive number of cases in which good tablets 5 are erroneously determined to be defective. It is being

The inspection simulation execution unit 751 changes the inspection condition data and instructs the inspection devices 22 to 24 to perform pass/fail judgment using the changed inspection condition data until all of the different types of tablets fail in the corresponding inspection item. This process is repeated until the product is determined to be non-defective or until the inspection condition data is changed to the limit of the changeable range.

Finally, if all of the different types of tablets are determined to be defective in the corresponding inspection item, the inspection simulation execution unit 751 marks the final judgment result regarding the inspection item as "detectable" through the inspection simulation process. , the inspection simulation process ends. The test data storage device 74 stores changed test condition data.

On the other hand, if at least one of the different types of tablets is determined to be a good product in the corresponding inspection item even though the inspection condition data has been changed to the limit of the changeable range, the inspection simulation execution unit 751 performs The final determination result regarding the inspection item is set as "undetectable" and the inspection simulation process is ended.

Note that the inspection simulation execution unit 751 can cause the inspection devices 22 to 24 to execute pass/fail determination for only some of the plurality of inspection items described above. For example, the inspection device 23 can be made to perform only the quality determination regarding the shape of the tablet 5.

The risk evaluation unit 752 determines that when the PTP sheet 1 is produced according to the production schedule, the tablets 5 accommodated in the PTP sheet 1 produced immediately before the next PTP sheet 1 are of a different type. The "risk" of the PTP sheet 1 containing different types of tablets being mistakenly mixed as tablets and flowing out to a process subsequent to the PTP packaging machine 10 is evaluated. In this embodiment, the risk evaluation section 752 has a function of evaluating "risk" related to the production schedule (input schedule and derived schedule) input by an operator or the like or derived by the schedule derivation section 731, and a schedule derivation section. It has a function to evaluate the "risk" related to the tentative schedule generated by 731. The process of evaluating "risk" by the risk evaluation unit 752 corresponds to a "risk evaluation process."

The risk evaluation unit 752 evaluates the "risk" based on the inspection items of the tablet 5 by the inspection devices 22 to 24 (in this embodiment, the shape, color, printing, and spectrum of the tablet 5). In other words, even if a different type of tablet is mistakenly mixed into the PTP sheet 1 to be produced next, the risk evaluation unit 752 can detect the different type of tablet as a defective product based on a certain inspection item. , the "risk" is assessed to be low in terms of the inspection items. On the other hand, if a different type of tablet is mistakenly mixed into the PTP sheet 1 to be produced next, and if the different type of tablet cannot be detected as a defective product in terms of a certain inspection item, the risk evaluation unit 752 performs an inspection. In terms of the items, the "risk" is evaluated as high. Note that the risk evaluation unit 752 can grasp the inspection items of the tablets 5 by the inspection devices 22 to 24 by using the inspection condition data stored in the inspection data management device 74.

Further, the risk evaluation unit 752 evaluates the “risk” based on the pass/fail determination result when the inspection simulation execution unit 751 causes the inspection devices 22 to 24 to execute the pass/fail determination based on the virtual dissimilar tablet image data. That is, the risk evaluation unit 752 evaluates the "risk" based on the final determination result from the inspection simulation process.

Here, the "risk" evaluation method by the risk evaluation unit 752 will be explained in more detail.

The risk evaluation unit 752 evaluates the "risk" focusing on the shape of the tablet 5, based on the fact that the inspection devices 22 and 23 determine whether the shape of the tablet 5 is good or bad. That is, the risk evaluation unit 752 executes the inspection simulation process and confirms the final determination result regarding the inspection item of shape. Then, if the determination result is "detectable", the risk evaluation unit 752 evaluates that the "risk" is low in terms of the shape of the tablet 5, and if the determination result is "undetectable", the risk evaluation unit 752 evaluates that the shape of the tablet 5 is low. The risk is assessed as high.

For example, the shape data TS1 of the tablet 5 related to the type K1 and the shape data TS2 of the tablet 5 related to the type K2 are sufficiently different (for example, the outer diameters of each are 1.0 mm or more). Therefore, when trying to produce product K2 following product K1, the final determination result regarding the inspection item of shape through the inspection simulation process will be "detectable." Therefore, the risk evaluation unit 752 evaluates that the "risk" in terms of the shape of the tablet 5 is low when trying to produce the variety K2 following the variety K1.

On the other hand, for example, as in the example shown in FIG. 12, it is assumed that the shape data TS1 of the tablet 5 related to the product type K1 and the shape data TS2' of the tablet 5 related to the product variety K2' are the same. In such a case, when trying to produce product K2 following product K1, the final determination result regarding the inspection item of shape based on the inspection simulation process will be "undetectable." Therefore, the risk evaluation unit 752 evaluates that the "risk" is high in terms of the shape of the tablet 5 when trying to produce the variety K2' following the variety K1.

Further, the risk evaluation section 752 evaluates the "risk" focusing on the printing section 5k, based on the fact that the inspection device 23 performs a quality determination on the printing section 5k. This "risk" evaluation is also performed based on the determination result from the inspection simulation process, as described above. That is, the risk evaluation unit 752 executes the inspection simulation process and confirms the final determination result regarding the inspection item of printing. Then, if the determination result is "detectable", the risk evaluation unit 752 evaluates that the "risk" of the printing section 5k is low, and if the determination result is "undetectable", the risk evaluation section 752 evaluates that the "risk" of the printing section 5k is low. The "risk" is assessed as high.

For example, print data TM1 of tablets 5 of type K1 and print data TM2 of tablets 5 of type K2 are sufficiently different in terms of the surface on which the printing section 5k is provided and the printed content. Therefore, when trying to produce type K2 following type K1, the final determination result regarding the inspection item of printing through the inspection simulation process will be "detectable." Therefore, the risk evaluation unit 752 evaluates that the "risk" is low in terms of the printing unit 5k when trying to produce the type K2 following the type K1.

In addition, the risk evaluation unit 752 performs a "risk" evaluation focusing on the color of the tablet 5, based on the fact that the inspection device 23 makes a quality determination regarding the color of the tablet 5. This "risk" evaluation is also performed based on the determination result from the inspection simulation process, as described above. That is, the risk evaluation unit 752 executes the inspection simulation process and confirms the final determination result regarding the inspection item of the color of the tablet 5. Then, if the determination result is "detectable", the risk evaluation unit 752 evaluates that the "risk" is low in terms of the color of the tablet 5, and if the determination result is "undetectable", the risk evaluation unit 752 evaluates that the color of the tablet 5 is low. The risk is assessed as high.

For example, color data TC1 of tablet 5 related to variety K1 and color data TC2 of tablet 5 related to variety K2 each indicate that tablet 5 is white, and there is no major difference between the two data TC1 and TC2. do not have. Therefore, when trying to produce product K2 following product K1, the final determination result regarding the inspection item of the color of tablet 5 through the inspection simulation process will be "undetectable." Therefore, the risk evaluation unit 752 evaluates that the "risk" is high in terms of the color of the tablets 5 when trying to produce the variety K2 following the variety K1.

In addition, the risk evaluation unit 752 performs a "risk" evaluation focusing on the spectrum of the tablet 5, based on the fact that the inspection device 24 makes a quality determination regarding the spectrum (components) of the tablet 5. This "risk" evaluation is also performed based on the determination result from the inspection simulation process, as described above. That is, the risk evaluation unit 752 executes the inspection simulation process and confirms the final determination result regarding the inspection item of the spectrum of the tablet 5. Then, if the determination result is "detectable", the risk evaluation unit 752 evaluates that the "risk" of the tablet 5 is low in terms of the spectrum (components), and if the determination result is "undetectable", the tablet The risk is assessed as high on the spectrum of 5.

For example, the spectrum data SP1 of the tablet 5 related to the product type K1 and the spectrum data SP2 of the tablet 5 related to the product type K2 are each data Y, and there is no major difference between the two data SP1 and SP2. Therefore, when trying to produce product K2 following product K1, the final determination result regarding the inspection item of the spectrum of tablet 5 through the inspection simulation process will be "undetectable." Therefore, the risk evaluation unit 752 evaluates that the "risk" is high in terms of the spectrum of the tablet 5 when trying to produce the variety K2 following the variety K1.

In addition to the "risk" evaluation based on the inspection items, the risk evaluation unit 752 also performs the following "risk" evaluation. That is, the risk evaluation unit 752 determines the size of the pocket portion 2 of the PTP sheet 1 to be produced next (referred to as "pocket size") and the tablet 5 accommodated in the PTP sheet 1 to be produced immediately before the PTP sheet 1. The "risk" is assessed based on the size of the tablet (referred to as "tablet size").

In the present embodiment, the risk evaluation unit 752 determines that the pocket size is smaller than the tablet size and that the tablet 5 of the PTP sheet 1 produced immediately before is physically attached to the pocket portion 2 of the PTP sheet 1 produced next. If it cannot be accommodated within the facility, the "risk" is assessed as low. On the other hand, the risk evaluation unit 752 determines that when the pocket size is larger than the tablet size and the tablet 5 related to the PTP sheet 1 to be produced immediately before can be accommodated in the pocket portion 2 of the PTP sheet 1 to be produced next, The "risk" is assessed as high.

For example, the pocket size related to variety K2 is larger than the tablet size related to variety K1, so when trying to produce variety K2 following variety K1, the pocket portion 2 related to variety K2 is used for the tablets related to variety K1. 5 can be physically accommodated. Therefore, the risk evaluation unit 752 evaluates that the "risk" is high in terms of size comparison between the tablet 5 and the pocket part 2.

The risk evaluation unit 752 performs the above-mentioned "risk" evaluation for each type change in the production schedule or tentative schedule. For example, when the production schedule is "K1→K2→K3", the risk evaluation unit 752 evaluates the "risk" when switching from product K1 to product K2 and the "risk" when switching from product K2 to product K3. Evaluate each.

The risk evaluation unit 752 then assigns a score according to the evaluated "risk." In this embodiment, when the risk evaluation unit 752 evaluates that the "risk" is low, it gives a risk score of 0 points, and when it evaluates that the "risk" is high, it gives a risk score of 10 points.

For example, assume that the production schedule is "K1→K2→K3". In this case, when switching from type K1 to type K2, as shown in FIG. 15, the risk score is 0 at point (a1) of the shape of tablet 5, and at point (b1) of printed part 5k The color point (c1) of the tablet 5 gives a score of 10, the spectrum point (d1) of the tablet 5 gives a score of 10, and the size comparison point of the tablet 5 and the pocket part 2 (e1) gives a score of 10. Become.

Furthermore, when switching from type K2 to type K3, as shown in FIG. 16, the risk score is 0 points at the point (a2) of the shape of the tablet 5, and 0 point at the point (b2) of the printing part 5k. Therefore, the color point (c2) of the tablet 5 is 0 points, the spectrum point (d2) of the tablet 5 is 0 points, and the size comparison point (e2) of the tablet 5 and the pocket part 2 is 10 points.

The risk evaluation unit 752 finally calculates the total risk score (total risk score). For example, in the above example, the score is 40 points. Based on the calculated total risk score, as described above, the schedule derivation unit 731 derives the production schedule that can most reduce the "risk" from among the plurality of provisional schedules. Further, based on the calculated total risk score, the risk reduction action execution unit 753 executes the action described below.

The risk reduction action execution unit 753 executes action to reduce “risk” based on the evaluation result by the risk evaluation unit 752. The step of executing the treatment by the risk reduction treatment execution unit 753 corresponds to a "risk reduction treatment execution step."

In this embodiment, in response to a request from an operator or the like (for example, input of a request through the input device 72), the risk evaluation section 752 calculates the production schedule (input schedule) input by the operator or the like and the schedule derivation section 731 derives the production schedule (input schedule). The “risk” related to the production schedule (derived schedule) is evaluated. Then, the risk reduction action execution unit 753 determines a production schedule with at least the lowest total risk score from among the input schedule and the derived schedule as the proposed schedule. Then, the risk reduction treatment execution unit 753 stores the determined proposed schedule in the schedule management device 73 and presents it to the operator etc. using the display device 71. Therefore, the risk reduction action execution unit 753 can execute a action using the production schedule derived by the schedule derivation unit 731 as a action to reduce “risk”.

Note that when there are multiple production schedules with the lowest total risk score, the risk reduction action execution unit 753 selects the production schedule input by the operator (input schedule) from among the production schedules with the lowest total risk score. Show matching items preferentially. Further, the risk reduction action execution unit 753 may be configured to present, for example, a plurality of production schedules in which the total risk score is equal to or less than a certain score.

Note that when the production schedule derivation function by the schedule derivation unit 731 is disabled, the risk reduction action execution unit 753 determines at least the lowest total risk score from among the production schedules (input schedules) input by the operator etc. The production schedule is presented as a proposed schedule.

An operator or the like can use the input device 72 to select and determine a production schedule to be used in actual production from among the presented production schedules (proposed schedules). The selected and determined production schedule (determined schedule) is displayed on the display device 71 and stored in the schedule management device 73. In the PTP packaging machine 10, PTP sheets 1 are produced according to the determined production schedule. Note that when producing the PTP sheet 1, the inspection condition data changed in the above-described risk avoidance process (step S14) is used as necessary.

Note that if the total risk score in the production schedule with the lowest total risk score is higher than the preset reference score, the risk reduction action execution unit 753, in addition to or instead of presenting the production schedule, displays the PTP sheet 1. Regarding cleaning of the PTP packaging machine 10 when changing the product type, measures may be taken to encourage longer cleaning time. Further, in addition to or in place of presenting the production schedule, an alarm or the like may be used to prompt a change in the input production schedule. Of course, measures other than these may also be performed.

As described in detail above, according to the present embodiment, the risk evaluation unit 752 uses the production schedule of the PTP sheet 1 to transfer the PTP sheet 1 (different type tablet container) containing different types of tablets to the PTP packaging machine 10. It is possible to evaluate the "risk" of leakage to subsequent processes. Then, based on the evaluation result by the risk evaluation unit 752, the risk reduction treatment execution unit 753 can execute a treatment to reduce the “risk”. Since the production schedule of the PTP sheet 1 is utilized in this way, the risk of dissimilar tablet containers flowing out can be more effectively reduced compared to a configuration in which dissimilar tablets are detected only by inspecting the tablets 5.

In addition, the risk evaluation unit 752 determines that the tablets stored in the PTP sheet 1 produced immediately before the next PTP sheet 1 are mixed in as a different type of tablet, and the different type of tablets are mixed in. Evaluate the "risk" of PTP sheets containing PTP sheets leaking to downstream processes from the container production equipment. Therefore, the risk evaluation unit 752 determines that the tablets accommodated in the PTP sheet 1 produced two or more times before the PTP sheet 1 produced next will be mistakenly mixed as different tablets. Do not evaluate the “risk” related to Therefore, it is possible to reduce the processing burden associated with risk evaluation.

Further, the risk evaluation unit 752 evaluates the "risk" based on the inspection items of the tablet 5 by the inspection devices 22 to 24. Therefore, "risk" can be appropriately and easily evaluated.

In addition, the risk evaluation unit 752 evaluates the “risk” based on the pass/fail determination results obtained when the inspection simulation execution unit 751 causes the inspection devices 22 to 24 to perform the pass/fail determination using the virtual dissimilar tablet image data. . Therefore, different tablets are appropriately detected as a result of the pass/fail judgment by the test devices 22 to 24 in advance, without actually performing a pass/fail judgment on the tablet 5 by the test devices 22 to 24 (a different tablet is judged to be defective). ) can be checked. This allows "risk" to be evaluated more appropriately.

In addition, the risk evaluation unit 752 determines the size of the pocket portion 2 (pocket size) in the PTP sheet 1 to be produced next, and the size of the tablet 5 (tablet) related to the PTP sheet 1 to be produced immediately before the PTP sheet 1. Assess “risk” based on size). Therefore, "risk" can be evaluated more appropriately.

In addition, the schedule derivation unit 731 can automatically derive a production schedule with low “risk,” and the risk reduction action execution unit 753 can take measures using the derived production schedule (for example, (e.g., presenting schedules). Therefore, "risk" can be further reduced.

Furthermore, since the production schedule can be automatically derived by the schedule derivation unit 731, it is no longer necessary for an operator or the like to create a production schedule. Therefore, convenience can be improved. For example, in this embodiment, when an operator etc. inputs only the product type of PTP sheet 1 to be produced, the schedule derivation unit 731 automatically derives a production schedule with low "risk" and executes risk reduction measures. The unit 753 can present the derived production schedule as a proposed schedule to an operator or the like. In this case, the derived schedule may be presented as it is as the proposed schedule without evaluating the "risk" for determining the proposed schedule from among the input schedule and the derived schedule.

Note that the present invention is not limited to the content described in the above embodiment, and may be implemented as follows, for example. Of course, other applications and modifications not exemplified below are also possible.

(a) In the above embodiment, the production schedule (proposed schedule) presented by the risk reduction action execution unit 753 and the production schedule (derived schedule) derived by the schedule derivation unit 731 are determined based on the total risk score. However, it may be determined based on other indicators.

For example, in a production schedule (input schedule, etc.) or a tentative schedule, the total risk score when switching the product type on PTP sheet 1 is calculated for each product change, and based on the multiple calculated total points, the proposed schedule or A derivation schedule may also be determined. In this case, the production schedule or tentative schedule with the lowest maximum value among the plurality of calculated total points may be determined as the proposed schedule or derived schedule.

To explain more specifically, in the example shown in FIG. 1 total score) will be 30 points, and the total risk score for the second product change (second total score) will be 10 points. On the other hand, suppose that in a certain production schedule X (provisional schedule X), the first total score and the second total score are each 20 points. In this case, the latter production schedule X (temporary schedule X) with a lower maximum value may be used as the proposed schedule or the derived schedule.

Further, the numerical value of the risk score (0 point or 10 point) mentioned above is an example, and this numerical value may be changed as appropriate. Of course, the risk score may be varied for each item used to evaluate "risk." For example, if the "risk" is high in terms of the shape of the tablet 5, the risk score may be set to 10 points, while if the "risk" is high in terms of the printing part 5k, the risk score may be set to 5 points. .

Furthermore, in the above embodiment, the risk score is set in two stages, but it may be multi-staged, such as three or more stages. In other words, the evaluation of "risk" may be performed in multiple stages of three or more instead of two stages of high and low.

In addition, if a different type of tablet can be detected as a defective product by inspection item 1 or by comparing the sizes of tablets 5 and pockets 2, the "risk" related to product type switching is evaluated to be low; The "risk" associated with this may be evaluated as high. For example, in the above embodiment, when trying to produce product K2 following product K1, different types of tablets can be detected as defective products based on inspection items such as shape and printing, and therefore different types of tablets can be rejected based on inspection items such as color. Even if it cannot be detected as a non-defective product, the "risk" associated with this product type switching may be evaluated as low.

(b) In the above embodiment, the inspection simulation execution unit 751 is used to evaluate “risk” based on inspection items, but it is not necessary to use the inspection simulation execution unit 751.

Therefore, each data (for example, inspection The "risk" may be evaluated based on the inspection items by comparing the shape data TS1, TS2, etc. stored in the data management device 74.

(c) In the above embodiment, the leakage risk management system 70 includes the schedule deriving unit 731 that automatically derives the production schedule, but may not include the schedule deriving unit 731. In this case, the spill risk management system 70 evaluates the "risk" using only the production schedule input by the operator, etc., and executes measures to reduce the "risk" based on the evaluation result.

(d) In the above embodiment, the PTP sheet 1 is mentioned as the "tablet container", but the tablet container is not limited to this. Therefore, the tablet container may be a blister sheet other than a PTP sheet, a bottle in which the tablets 5 are stored, or the like.

When the tablet accommodating body is a bottle as described above, the accommodating body production device for producing the bottles includes a conveying means for conveying the tablets 5 (for example, a suction belt that conveys the tablets 5 while adsorbing them), and a conveying means for conveying the tablets 5 while adsorbing them. an imaging means for taking an image of the tablet 5 to obtain image data; an inspection means for determining the quality of the tablet 5 based on the image data obtained by the imaging means; and storing the tablet 5 after the inspection in a bottle. It may also be equipped with a storage means for. Of course, the container production apparatus may be provided with a printing means for providing the printing section 5k on the tablet 5, if necessary. When using such a container production device, the risk evaluation section 752 can evaluate the "risk" based on the inspection items of the tablet 5 by the inspection means, and the risk reduction treatment execution section 753 can evaluate the Based on the results, actions can be taken to reduce the "risk."

Note that when the tablet container is a bottle as described above, the virtual dissimilar tablet image data is different from the background image data as base data (for example, the image data of the conveyance means acquired by the imaging means), and the tablet image data It can be generated by pasting data.

(e) In the above embodiment, the leakage risk management system 70 corresponds to one PTP packaging machine 10. On the other hand, the leakage risk management system 70 may be compatible with a plurality of PTP packaging machines 10. In this case, the leakage risk management system 70 evaluates the "risk" for each PTP packaging machine 10 according to the settings of each PTP packaging machine 10 (for example, inspection items for the tablets 5).

(f) There are no particular limitations on the number or arrangement positions of inspection devices provided in the PTP packaging machine 10. Therefore, for example, an inspection device corresponding to the transport path of the PTP film 6 may be provided.

Further, in the above embodiment, the inspection items of the tablet 5 in the PTP packaging machine 10 are the shape, the printed part 5k, the color, and the spectrum, but the inspection items of the tablet 5 in the PTP packaging machine 10 are limited to these. That doesn't mean it's true.

Therefore, for example, the PTP packaging machine 10 may have one inspection device, and this inspection device may only perform quality determination regarding the shape of the tablet 5. In this case, the leakage risk management system 70 can evaluate the "risk" by focusing on the shape of the tablet 5.

Further, the PTP packaging machine 10 may not include an inspection device and may not judge the quality of the tablets 5. In this case, based on the size (pocket size) of the pocket portion 2 in the PTP sheet 1 to be produced next and the size (tablet size) of the tablet 5 related to the PTP sheet 1 to be produced immediately before the PTP sheet 1, By evaluating the "risk", the "risk" can be evaluated even if the PTP packaging machine 10 is not equipped with an inspection device.

(g) In the above embodiment, the disk-shaped tablet 5 is used which is circular in plan view, but the shape of the tablet is not limited to the circular shape in plan view. Therefore, the tablet may have, for example, a polygonal shape in a plan view, an elliptical shape in a plan view, an elliptical shape in a plan view, or the like.

Furthermore, tablets include not only medicines but also tablets used for eating and drinking, for example. Furthermore, tablets include not only plain tablets, but also sugar-coated tablets, film-coated tablets, orally disintegrating tablets, enteric-coated tablets, gelatin-coated tablets, capsule tablets, and the like.

1... PTP sheet (tablet container, blister sheet), 2... pocket part, 3... container film, 5... tablet, 10... PTP packaging machine (container production device), 22... first inspection device (inspection means), 23...Second inspection device (inspection means), 24...Third inspection device (inspection means), 51...Inspection camera (imaging means), 70...Different tablet outflow risk management system, 73...Schedule management device (schedule management means) ), 100...Container production system, 731...Schedule derivation unit (schedule derivation means), 751...Inspection simulation execution unit (inspection simulation execution unit), 752...Risk evaluation unit (risk evaluation means), 753...Risk reduction action execution Department (Risk Reduction Measures Execution Means).

Claims (8)

Dissimilar tablet leakage risk management applied to container production equipment that is capable of switching the type of tablets accommodated and that can sequentially produce tablet containers containing different tablets each time the type is changed. A system,
schedule management means for managing a production schedule including information regarding the production order of the tablet containers by the container production device;
When the tablet accommodating bodies are produced according to the production schedule, the tablets stored in the tablet accommodating body produced immediately before the next produced tablet accommodating body are mistakenly treated as different tablets. a risk evaluation means for evaluating the risk that the tablet container containing the different types of tablets will flow out to a downstream process from the container production device;
A risk management system for dissimilar tablet leakage, comprising: a risk reduction action execution means capable of executing action for reducing the risk based on the evaluation result by the risk evaluation means. The container production device has an inspection means for determining the quality of the tablet,
2. The dissimilar tablet leakage risk management system according to claim 1, wherein the risk evaluation means is configured to be able to evaluate the risk based on inspection items of the tablets by the inspection means. 3. The dissimilar tablet leakage risk management system according to claim 2, wherein the inspection items include at least one of the color, shape, printing, marking, and spectrum of the tablet. The container production device has an imaging means for imaging the tablet,
The inspection means is configured to make a quality determination regarding the tablet based on the image data obtained by the imaging means,
The image data of the tablets related to the tablet container produced immediately before the tablet container is used for the inspection means configured to inspect the tablets related to the tablet container to be produced next. and an inspection simulation execution means for executing a pass/fail judgment based on virtual dissimilar tablet image data generated by
The risk evaluation means is configured to be capable of evaluating the risk based on a quality determination result obtained when the inspection simulation execution means causes the inspection means to perform quality determination based on the virtual dissimilar tablet image data. The dissimilar tablet outflow risk management system according to claim 2, characterized in that: The tablet container is a blister sheet in which tablets are stored in pockets formed in a container film,
The risk evaluation means is capable of evaluating the risk based on the size of the pocket portion of the blister sheet to be produced next and the size of the tablet accommodated in the blister sheet to be produced immediately before the blister sheet. The dissimilar tablet outflow risk management system according to claim 1, wherein the system is configured to: The means for generating a plurality of provisional schedules including information regarding the production order of the tablet containers based on information about the plurality of tablet containers to be produced, and the risk evaluation means when the tablet containers are produced according to the tentative schedule. comprising a schedule deriving means configured to be able to derive at least the production schedule that can most reduce the risk from among the plurality of provisional schedules based on the evaluation result by;
According to claim 1, the risk reduction action execution means is configured to be able to execute a action using the production schedule derived by the schedule derivation means as the action for reducing the risk. Dissimilar tablet risk management system described. The dissimilar tablet leakage risk management system according to claim 1;
A container production system comprising the container production device. Dissimilar tablet leakage risk management applied to container production equipment that is capable of switching the type of tablets accommodated and that can sequentially produce tablet containers containing different tablets each time the type is changed. A method,
When the tablet containers are produced according to a production schedule including information regarding the production order of the tablet containers by the container production device, for the next tablet container to be produced, the tablet container is produced immediately before the tablet container is produced. A risk assessment for evaluating the risk that tablets accommodated in the tablet accommodating body are mistakenly mixed as different tablets, and the tablet accommodating body mixed with the dissimilar tablets flows out to a downstream process from the accommodating body production device. process and
A method for managing the risk of outflow of different types of tablets, comprising: a risk reduction treatment execution step of executing treatment to reduce the risk based on the evaluation result of the risk evaluation step.

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