System for managing risk of outflow of dissimilar tablets, method for managing risk of outflow of dissimilar tablets, and container production system

Abstract

Provided are a system and the like for managing the risk of outflow of a dissimilar tablet, which can more effectively reduce the risk of outflow of a dissimilar tablet container to a subsequent process. A dissimilar tablet outflow risk management system (70) is provided with a risk assessment unit (752) and a risk reduction measure execution unit (753). A risk assessment unit (752) assesses a risk in which, when a PTP sheet is produced in accordance with a production schedule, a tablet, which is a dissimilar tablet and is housed in a PTP sheet produced once before the PTP sheet, is mistakenly mixed into a PTP sheet to be produced, and the PTP sheet mixed with the dissimilar tablet is discharged to a subsequent process than a PTP packaging machine (10). A risk reduction measure execution unit (753) can execute a measure for reducing the risk on the basis of the evaluation result of the risk evaluation unit (752).

Description

Technical Field

[0001] The present invention relates to a system and method for reducing the risk of a tablet container containing tablets of different kinds mistakenly mixed therein flowing out to a subsequent process, and a container production system equipped with the system. Background Art

[0002] In general, tablet containers for storing tablets are widely used in the fields of pharmaceuticals and foods. Examples of tablet containers include blister sheets and bottles filled with tablets. The blister sheet is composed of a container film having a pocket filled with tablets and a cover film attached to the container film so as to seal the opening side of the pocket.

[0003] The tablet container is produced by a container production device. A blister packaging machine as a container production device for producing blister sheets includes, for example, a device for forming a pocket on a strip-shaped container film, a device for filling the pocket with tablets, and a device for attaching a cover film to the container film.

[0004] However, a general container production device is configured to switch the type of tablets to be contained, and each time the type is switched, tablet containers of different types containing different tablets can be produced in sequence. Here, when the type of tablet container to be produced is switched, in order to prevent tablets related to the tablet container produced once before (just before) from being mistakenly mixed into the tablet container to be produced next as tablets of different types, the container production device is cleaned, etc., but there is still a possibility that tablets of different types may be mixed.

[0005] Therefore, in order to prevent tablet containers containing tablets of different types (hereinafter referred to as "different-type tablet containers") from flowing out to the post-process of a container production device, a method for detecting tablets of different colors or shapes as different-type tablets by an inspection device provided in a container production device has been proposed (for example, see Patent Document 1). In addition, a method for detecting different-type tablets by using the area or spectral analysis of a region related to the tablet is also known (for example, see Patent Documents 2, 3, etc.).

[0006] Prior art literature

[0007] Patent Literature

[0008] Patent Document 1: Japanese Patent Application Publication No. 2015-200595

[0009] Patent Document 2: Japanese Patent Application Publication No. 2011-112527

[0010] Patent Document 3: Japanese Patent Application Publication No. 2018-179568 Summary of the invention

[0011] Problems to be solved by the invention

[0012] In addition, the lower the risk of the different-type tablet container flowing out to a later process than the container production device, the better. However, the above methods are only methods of detecting different-type tablets by actually inspecting the tablets. Therefore, in order to further reduce the outflow risk in these methods, it is necessary to add a new inspection device, etc., which can perform inspections on inspection items different from those previously performed. However, the degree of reduction in the outflow risk caused by adding a new inspection device is also limited.

[0013] The present invention has been developed in view of the above situation, and its object is to provide a management system for the risk of outflow of different-type tablets, etc., which can more effectively reduce the risk of outflow of different-type tablet containers to subsequent processes.

[0014] Technical solutions to solve problems

[0015] The following is a detailed description of each technical solution suitable for solving the purpose. In addition, if necessary, the corresponding technical solution is annotated with its unique effects.

[0016] Technical Solution 1. A risk management system for outflow of tablets of different types, which is applied to a container production device, wherein the container production device can switch the types of tablets to be contained, and each time the types are switched, tablet containers containing different tablets are produced in sequence, wherein the risk management system for outflow of tablets of different types has:

[0017] a progress management mechanism that manages a production progress including information related to a production sequence of the tablet containers by the container production device;

[0018] a risk assessment unit that assesses a risk, when the tablet containers are produced according to the production schedule, that is, a risk that a tablet that is considered to be a different type of tablet and is contained in a tablet container produced once before the tablet container is mistakenly mixed into the tablet container to be produced next, and the tablet container mixed with the different type of tablet flows to a process later than the container production device; and

[0019] The risk reduction measures implementation agency can implement measures for reducing the risk based on the assessment results of the risk assessment agency.

[0020] In addition, the production progress managed by the progress management mechanism may be input and stored in advance by an operator, etc., or may be automatically derived (generated) by a progress derivation mechanism as shown in the technical solution 6 described later.

[0021] In terms of "measures to reduce the risk", for example, measures to prompt changes in production schedules using alarms, etc.; measures to prompt production schedules that can further reduce the risk of outflow; measures to prompt longer cleaning time for cleaning of the container production device when switching the type of tablet container, etc. Here, "measures to prompt production schedules that can further reduce the risk of outflow" include: measures to prompt one or more production schedules from a plurality of pre-stored production schedules; measures to automatically derive a production schedule and prompt the derived production schedule.

[0022] According to the technical solution 1, the risk assessment means can assess the risk of tablet containers mixed with heterogeneous tablets (heterogeneous tablet containers) flowing out to a process later than the container production device by using the production progress of the tablet containers. Moreover, based on the assessment result of the risk assessment means, the risk reduction measure execution means can execute measures for reducing the risk. Because the production progress of the tablet containers is utilized in this way, the risk of heterogeneous tablet containers flowing out can be more effectively reduced than detecting the composition of heterogeneous tablets only by tablet inspection.

[0023] In addition, since the container production device is usually cleaned each time the type of tablet container to be produced is switched, it is unlikely that tablets related to tablet containers produced two or more times before the tablet container are mistakenly mixed into the tablet container to be produced next. In view of this, the risk assessment unit assesses the risk that tablets that are regarded as tablets of a different type and are contained in the tablet container produced once before the tablet container are mistakenly mixed into the tablet container to be produced next, and the tablet container mixed with the tablets of the different type flows to a process later than the container production device. Therefore, it is possible to attempt to reduce the processing burden associated with the risk assessment.

[0024] Technical Solution 2. The risk management system for outflow of heterogeneous tablets described in Technical Solution 1 is characterized in that the container production device has an inspection mechanism that determines whether the tablets are qualified;

[0025] The risk assessment means is configured to assess the risk based on the inspection items of the tablets performed by the inspection means.

[0026] According to the technical solution 2, the risk assessment agency can assess the risk based on the inspection items of the tablets performed by the inspection agency. For example, in the case where the inspection items of the tablets performed by the inspection agency only include "tablet color", after producing the tablet container Aw1 containing the white tablet aw1, when producing the tablet container Br2 containing the red tablet br2, the risk management agency assesses the risk to be low because the inspection agency can detect the white tablet aw1 as a different type of tablet when producing the tablet container Br2. On the other hand, in the case where the inspection items of the tablets performed by the inspection agency only include "tablet color", after producing the tablet container Aw1 containing the white tablet aw1, when producing the tablet container Bw2 containing the white tablet bw2, the risk management agency assesses the risk to be high because it is difficult to detect the tablet aw1 as a different type of tablet when producing the tablet container Bw2. In this way, the risk can be appropriately and easily assessed by using the inspection items of the tablets performed by the inspection agency.

[0027] Technical Solution 3. The heterogeneous tablet outflow risk management system described in Technical Solution 2 is characterized in that the inspection items include at least one of the tablets' color, shape, printing, engraving, and spectrum.

[0028] According to the technical solution 3, the same effect as the technical solution 2 is basically achieved. In addition, in terms of more appropriately evaluating the risk, the more inspection items there are, the better.

[0029] Technical Solution 4. The risk management system for outflow of heterogeneous tablets described in Technical Solution 2 is characterized in that the container production device has a camera mechanism for photographing tablets;

[0030] The inspection mechanism is configured to make a determination on whether the tablet is acceptable based on the image data obtained by the imaging mechanism;

[0031] An inspection simulation executing means is provided for executing a pass / fail determination on the inspection means set to inspect the tablets associated with the tablet container to be produced next, based on virtual tablet image data of a different type, the virtual tablet image data of a different type being generated using image data of tablets associated with the tablet container produced once before the tablet container;

[0032] The risk assessment unit is configured to assess the risk based on a conformity determination result obtained when the inspection simulation execution unit performs conformity determination on the inspection unit based on the virtual heterogeneous tablet image data.

[0033] According to the fourth technical solution, the inspection simulation execution mechanism performs a qualification determination on the inspection mechanism after the setting of the inspection of the tablets related to the tablet container to be produced next, using the virtual heterogeneous tablet image data. Moreover, the risk assessment mechanism can assess the risk based on the qualification determination result when the inspection simulation execution mechanism uses the virtual heterogeneous tablet image data to perform the qualification determination on the inspection mechanism. Therefore, without actually performing the qualification determination of the tablets by the inspection mechanism, it can be confirmed in advance whether the heterogeneous tablets are properly detected (the heterogeneous tablets are determined to be defective). As a result, the risk can be more appropriately assessed.

[0034] Technical Solution 5. The heterogeneous tablet outflow risk management system described in Technical Solution 1 is characterized in that the tablet container is a blister sheet, and the blister sheet is formed by accommodating the tablets in a pocket formed by a container film;

[0035] The risk assessment mechanism is configured to assess the risk based on the size of the pocket of the blister sheet to be produced next and the size of the tablets contained in the blister sheet produced once before the blister sheet.

[0036] According to the technical solution 5, the risk assessment agency can assess the risk based on the size of the bag portion of the blister sheet to be produced next (hereinafter referred to as "bag size") and the size of the tablets related to the blister sheet produced once before the blister sheet (hereinafter referred to as "tablet size"). For example, in the case where the bag size is smaller than the tablet size, the risk assessment agency assesses the risk to be low because the bag portion of the blister sheet to be produced next cannot physically accommodate the tablets related to the blister sheet produced previously. On the other hand, for example, in the case where the bag size is larger than the tablet size, the risk assessment agency assesses the risk to be high because the bag portion of the blister sheet to be produced next can accommodate the tablets related to the blister sheet produced previously. Therefore, according to the technical solution 5, the risk can be more appropriately assessed.

[0037] Furthermore, according to the fifth aspect, since the risk is evaluated based on the size of the bag or tablet, the risk can be evaluated even if the container production device does not have an inspection mechanism. Furthermore, measures for reducing the risk can be taken based on the evaluation results.

[0038] Technical Solution 6. The heterogeneous tablet outflow risk management system described in Technical Solution 1 is characterized by comprising a schedule derivation mechanism, which is configured in the following manner: based on information about a plurality of tablet containers scheduled to be produced, a plurality of tentative schedules including information related to the production sequence of the tablet containers are generated, and based on the evaluation result of the risk evaluation mechanism when the tablet containers are produced according to the tentative schedules, at least the production schedule that can best reduce the risk can be derived from the plurality of tentative schedules;

[0039] The risk reduction measure execution unit is configured to execute a measure using the production schedule derived by the schedule deriving unit as a measure for reducing the risk.

[0040] According to the sixth technical solution, the production schedule with low outflow risk can be automatically derived by the schedule derivation mechanism, and the risk reduction measure execution mechanism can take measures using the derived production schedule (for example, prompting the derived production schedule, etc.). Therefore, the risk can be further reduced. In addition, since the production schedule by the operator is not necessary, the convenience can be improved.

[0041] Technical Solution 7. A container production system comprising: the heterogeneous tablet outflow risk management system described in Technical Solution 1; and the container production device.

[0042] According to the technical solution 7, the same effect as the technical solution 1 is achieved.

[0043] Technical Solution 8. A method for managing the outflow risk of heterogeneous tablets, which is applied to a container production device, the container production device can switch the type of tablets to be contained, and each time the type is switched, tablet containers containing different tablets are produced in sequence, wherein the method for managing the outflow risk of heterogeneous tablets comprises:

[0044] a risk assessment step of assessing a risk when the tablet container is produced according to a production schedule including information related to a production sequence of the tablet container by the container production apparatus, the risk being that a tablet that is considered to be a different type of tablet and that was contained in a tablet container produced once before the tablet container is mistakenly mixed into the tablet container to be produced next, and the tablet container mixed with the different type of tablet flows to a process later than the container production apparatus; and

[0045] The risk reduction measure execution step executes a measure for reducing the risk according to the evaluation result of the risk evaluation step.

[0046] According to the technical solution 8, the same effect as the technical solution 1 is achieved.

[0047] In addition, the technical matters related to the above-mentioned technical solutions may be appropriately combined. For example, the technical matters related to the above-mentioned technical solution 2 or 3 may be combined with at least one of the technical matters related to the above-mentioned technical solutions 4 to 6. Also, for example, the technical matters related to the above-mentioned technical solution 7 or 8 may be combined with at least one of the technical matters related to the above-mentioned technical solutions 1 to 6. BRIEF DESCRIPTION OF THE DRAWINGS

[0048] Figure 1 It is a three-dimensional diagram showing a PTP sheet.

[0049] Figure 2 This is a partially enlarged cross-sectional view of the PTP sheet.

[0050] Figure 3 It is a top view showing the PTP sheet.

[0051] Figure 4 It is a three-dimensional diagram showing a PTP film.

[0052] Figure 5 This is a block diagram showing the general structure of the container production system.

[0053] Figure 6 This is a schematic diagram showing the general structure of a PTP packaging machine.

[0054] Figure 7 This is a block diagram showing the electrical configuration of the inspection device.

[0055] Figure 8 This is a schematic diagram showing a rough configuration of an inspection camera in the third inspection device.

[0056] Fig. 9 This is a table showing inspection items of tablets performed by each inspection device.

[0057] Fig.10 This is a table showing various data stored in the inspection data management device.

[0058] Fig.11 This is a graph showing an example of shape data, etc.

[0059] Fig.12 This is a graph showing other examples of shape data, etc.

[0060] Fig.13 This is a schematic diagram showing an example of information displayed on the display device.

[0061] Fig.14 It is a flowchart of the inspection simulation process.

[0062] Fig.15This is an explanatory diagram for explaining the risk point number when switching from category K1 to category K2.

[0063] Fig.16 This is an explanatory diagram for explaining the risk point number when switching from category K2 to category K3. DETAILED DESCRIPTION

[0064] Hereinafter, embodiments will be described with reference to the drawings. First, the structure of the PTP sheet will be described.

[0065] like Figure 1 , Figure 2 As shown, the PTP sheet 1 comprises a container film 3 having a plurality of pockets 2 and a cover film 4 attached to the container film 3 to seal the pockets 2. In the present embodiment, the PTP sheet 1 corresponds to a "tablet packaging body" and a "blister sheet".

[0066] The container film 3 is formed 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 formed of an opaque material (such as aluminum foil) provided with a sealing layer on the surface, and the sealing layer is formed of, for example, polypropylene resin. Of course, the materials of the films 3 and 4 are not limited to these, and other materials may be used.

[0067] The PTP sheet 1 is formed by placing a PTP film 6 (see Figure 4 ) is punched into a sheet and formed into a roughly rectangular shape when viewed from above. The PTP film 6 is formed by a strip-shaped container film 3 and a strip-shaped cover film 4.

[0068] In the PTP sheet 1, two rows of pockets are formed in the short-side direction thereof, and the pockets are composed of five pockets 2 arranged along the long-side direction thereof. That is, a total of ten pockets 2 are formed. In addition, one tablet 5 is accommodated in each pocket 2. The structure is such that when the PTP sheet 1 is viewed from the front side (the protruding side of the pocket 2), the tablet 5 can be seen through the pocket 2.

[0069] The tablet 5 is a disc-shaped bare chip which is circular when viewed from above and is configured to have a side surface 5a, and a front surface 5b and a back surface 5c sandwiching the side surface 5a. In addition, a printing portion 5k is provided on the front surface 5b and the back surface 5c (see Figure 3 ), the printing unit 5k prints characters, symbols, numbers, graphics, etc. representing product information related to the tablet 5. The product information related to the tablet 5 may include "product name", "content", "tablet shape", "manufacturer", and "batch number".

[0070] In addition, the above-mentioned structure of the PTP sheet 1 is purely an example, and the structure of the PTP sheet 1 can be appropriately changed. Therefore, for example, the number or shape of the bag parts 2, the type of tablets 5 contained in the bag parts 2 (color, shape, presence or absence of the printing part 5k, and composition, etc.) can be appropriately changed.

[0071] Secondly, refer to Figure 5 The structure of the container production system 100 is described, and the container production system 100 includes a PTP packaging machine 10 for manufacturing the PTP sheet 1, and a heterogeneous tablet outflow risk management system 70 (hereinafter simply referred to as "outflow risk management system 70") used by the PTP packaging machine 10. In this embodiment, the PTP packaging machine 10 constitutes a "container production device." First, the PTP packaging machine 10 is described.

[0072] The PTP packaging machine 10 is a device that can switch the type of tablets 5 contained in the bag portion 2, and can sequentially produce PTP sheets 1 containing different tablets 5 each time the type is switched. However, when the type of tablets 5 is switched to change the type of PTP sheet 1 to be manufactured, the PTP packaging machine 10 is cleaned or components (for example, components of the bag portion forming device 16 described later) are replaced.

[0073] like Figure 6 As shown in FIG. 1 , a raw material of a strip-shaped container film 3 is wound into a roll shape at the most upstream side of a PTP packaging machine 10. The unwinding end side of the container film 3 wound into a roll shape is guided by guide rollers 11 and 12. The container film 3 is hung on an intermittent feed roller 13 at the downstream side of the guide rollers 11 and 12. The intermittent feed roller 13 is connected to a motor that rotates intermittently to convey the container film 3 intermittently.

[0074] A heating device 15 and a pocket forming device 16 are sequentially arranged between the guide roller 12 and the intermittent feed roller 13 along the conveying path of the container film 3. Then, after the container film 3 is heated by the heating device 15 and the container film 3 is made relatively soft, a plurality of pockets 2 are formed at predetermined positions of the container film 3 by the pocket forming device 16. The pockets 2 are formed during the intervals between the conveying actions of the container film 3 by the intermittent feed roller 13.

[0075] The container film 3 fed from the intermittent feed roller 13 is sequentially hung on the guide roller 17, the tension roller 18, and the film receiving roller 20. The film receiving roller 20 is connected to a motor that rotates at a constant speed, so it continuously and at a constant speed conveys the container film 3. The tension roller 18 sets the container film 3 to a state of being stretched toward the tension side by elastic force, and prevents the container film 3 from being loosened due to the difference in conveying motion between the intermittent feed roller 13 and the film receiving roller 20, and keeps the container film 3 in a tensioned state.

[0076] A filling device 21, a first inspection device 22, a second inspection device 23, and a third inspection device 24 are sequentially arranged upstream of the film receiving roller 20 along the conveying 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 mechanism".

[0077] The filling device 21 includes, for example, a cylindrical chute for accommodating the tablets 5 in a row, and a shutter (not shown) for opening and closing the outlet of the chute; the tablets 5 are filled (accommodated) in the bag portion 2 by opening the shutter at a predetermined time.

[0078] The first inspection device 22, the second inspection device 23, and the third inspection device 24 each perform at least a pass / fail determination on the tablet 5. The detailed configuration of the inspection devices 22 to 24 will be described later.

[0079] On the other hand, the raw material for forming the strip-shaped cover film 4 is wound into a roll at the most upstream side. The delivery end of the cover film 4 wound into a roll is guided to the heating roller 26 side by the guide roller 25 .

[0080] The heated roller 26 can be pressed against the film receiving roller 20, and the container film 3 and the cover film 4 are fed between the two rollers 20 and 26. Then, the two films 3 and 4 are passed between the two rollers 20 and 26 in a heated and pressed state, and the two films 3 and 4 are attached, and the bag part 2 is sealed with the cover film 4. Thus, the strip-shaped PTP film 6 in which the tablets 5 are accommodated in each bag part 2 is manufactured.

[0081] The PTP film 6 fed from the film receiving roller 20 is sequentially hung on the tension roller 27 and the intermittent feed roller 28. The intermittent feed roller 28 is connected to a motor that rotates intermittently, so it intermittently transports the PTP film 6. The tension roller 27 sets the PTP film 6 to a state of being stretched toward the tension side by elastic force, preventing the PTP film 6 from being relaxed due to the difference in the transporting action between the film receiving roller 20 and the intermittent feed roller 28, and keeping the PTP film 6 in a tensioned state.

[0082] The PTP film 6 fed from the intermittent feed roller 28 is sequentially hung on the tension roller 31 and the intermittent feed roller 32. Since the intermittent feed roller 32 is connected to a motor that rotates intermittently, the PTP film 6 is intermittently conveyed. The tension roller 31 sets the PTP film 6 to a state of being stretched toward the tension side by elastic force, thereby preventing the PTP film 6 from being relaxed between the intermittent feed rollers 28 and 32.

[0083] Between the intermittent feed roller 28 and the tension roller 31, along the conveying path of the PTP film 6, a slit forming device 33 and an imprinting device 34 are sequentially arranged. The slit forming device 33 has a function of forming a separation slit at a predetermined position of the PTP film 6. The imprinting device 34 has a function of adding an imprint at a predetermined position of the PTP film 6. Figure 1 In the figures, the separation slits or marks are omitted.

[0084] The PTP film 6 fed from the intermittent feed roller 32 is sequentially hung on the tension roller 35 and the continuous feed roller 36 on its downstream side. A sheet punching device 37 is arranged between the intermittent feed roller 32 and the tension roller 35 along the conveying path of the PTP film 6. The sheet punching device 37 punches the outer edge of the PTP film 6 into a PTP sheet 1 unit. Thus, the PTP sheet 1 is obtained.

[0085] The obtained PTP sheet 1 is transported by the conveyor belt 39 and temporarily stored in the finished product hopper 40. However, the PTP sheet 1 containing the tablets 5 determined as defective by at least one of the inspection devices 22, 23, and 24 is not sent to the finished product hopper 40, but is discharged separately by a defective sheet discharge mechanism (not shown).

[0086] A cutting device 41 is provided on the downstream side of the continuous feed roller 36. After being guided to the tension roller 35 and the continuous feed roller 36, the unnecessary film portion 42 constituting the residual material portion (waste material portion) is guided to the cutting device 41. The residual material portion remains in a strip shape after being punched by the sheet punching device 37. The cutting device 41 cuts the unnecessary film portion 42 into a predetermined size. The cut unnecessary film portion 42 (waste material portion) is stored in the waste material hopper 43 and then disposed of separately.

[0087] Secondly, refer to Figure 7 , a more specific structure of the above-mentioned inspection devices 22 to 24 will be described. Each of the inspection devices 22 to 24 includes a lighting device 50, an inspection camera 51, and a pass / fail determination device 52. In this embodiment, the inspection camera 51 constitutes an "imaging mechanism".

[0088] The lighting device 50 irradiates the container film 3 or the tablet 5 with predetermined light (e.g., near-infrared light or visible light) from the opening side or the protruding side of the bag portion 2. In addition, the lighting device 50 of the third inspection device 24 can irradiate near-infrared light, and irradiate the near-infrared light to a predetermined area of ​​the container film 3 from obliquely above. As the lighting device 50 of the third inspection device 24, for example, a halogen lamp can be used, which can emit near-infrared light with a continuous spectrum (e.g., a near-infrared light region with a wavelength of 700 to 2500 nm). In addition, as a light source other than a halogen lamp, a deuterium discharge tube, a tungsten filament lamp, a xenon lamp, etc. can be used.

[0089] The inspection camera 51 takes an image of the container film 3 or the tablet 5. In the present embodiment, a CCD camera having sensitivity in the wavelength region of the light irradiated from the lighting device 50 is used as the inspection camera 51. In addition, a color CCD camera is used as the inspection camera 51 of the second inspection device 23 in order to be able to recognize colors. In addition, a CMOS camera may be used instead of the CCD camera. In the present embodiment, the inspection camera 51 of the first inspection device 22 obtains brightness image data, and the inspection camera 51 of the second inspection device 23 obtains color image data.

[0090] The inspection camera 51 of the third inspection device 24 is used to obtain spectral image data related to the tablet 5, and includes an optical lens 511, a two-dimensional spectrometer 512, and a camera unit 513 (see FIG. Figure 8 ).

[0091] The optical lens 511 is composed of a plurality of lenses not shown in the figure, and is configured to make the incident light parallel. The optical axis of the optical lens 511 is set along the vertical direction. In addition, the optical lens 511 is set to image the incident light at the position of the slit 512a described later of the two-dimensional beam splitter 512.

[0092] The two-dimensional spectrometer 512 is composed of a slit 512a, an incident side lens 512b, a spectrometer 512c, and an emission side lens 512d. The spectrometer 512c is composed of an incident side prism 512ca, a transmission type diffraction grating 512cb, and an emission side prism 512cc.

[0093] The slit 512a is formed between a pair of substantially flat slit plates 514. The slit 512a is formed as an elongated substantially rectangular (linear) opening, the width direction (short side direction) of which is arranged along the conveying direction of the container film 3, and the long side direction of which is arranged along a direction orthogonal to the conveying direction.

[0094] In this configuration, light passing through the slit 512a is converted into parallel light by the incident side lens 512b, then split by the spectroscopic unit 512c, and then formed into a two-dimensional spectroscopic image (spectral spectrum) on the camera unit 513 by the emission side lens 512d.

[0095] The camera component 513 has a light receiving surface 513a formed by a two-dimensional arrangement of a plurality of light receiving components (pixels) 515. As the camera component 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 used. Of course, the camera component is not limited thereto, and other sensors having sensitivity in the near infrared region (such as a CMOS sensor or an MCT (HgCdTe) sensor, etc.) can also be used.

[0096] Spectra (wavelength component light) of the reflected light reflected by the container film 3 or the tablet 5 are received by each light receiving element (each pixel) 515 of the imaging element 513. Then, spectral image data corresponding to the light intensity of the received light is input to the acceptance judging device 52.

[0097] In addition, the image data (brightness image data, color image data, and spectral image data) obtained by the inspection camera 51 is converted into a digital signal inside the inspection camera 51 and then input to the acceptance judgment device 52 in the form of a digital signal.

[0098] The conformity determination device 52 is constituted by a so-called computer system including a CPU as a computing unit, a ROM storing various programs, a RAM temporarily storing various data such as computing data and input / output data, and a storage medium storing various data for a long period of time. The conformity 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, a CPU, and an input / output interface 58.

[0099] The image memory 53 stores the image data obtained by the inspection camera 51. In addition, in the qualification determination device 52, spectral data is generated based on the spectroscopic image data, and the spectral data is sequentially stored in the image memory 53 in a time series. Thus, two-dimensional image data (spectral image data) having spectral data for each pixel is obtained. Moreover, the inspection is performed based on the image data (brightness image data, color image data, and spectral image data) stored in the image memory 53. Of course, when performing the inspection, the image data can also be processed (for example, binarization processing, etc.). For example, the processed image data is also stored in the image memory 53.

[0100] The inspection result storage device 54 stores data on the pass / fail determination results, statistical data on which probability statistics processing has been performed on the data, and the like.

[0101] The determination memory 55 is used to store various information used in the determination. The various information includes a determination criterion (such as a threshold value) for determining whether the product is acceptable, a binarization threshold value for binarization, and data for defining the inspection object range (such as information for specifying the tablet 5 portion in the image data).

[0102] Information corresponding to the type of the tablet 5 to be inspected is input from the inspection data management device 74 described later to the determination memory 55. Therefore, at least information (inspection condition data) required for making a pass / fail determination of the tablet 5 to be inspected is stored in the determination memory 55. The information stored in the determination memory 55 can be changed, added, or deleted by the inspection data management device 74.

[0103] The inspection condition storage device 56 stores the date and time of the conforming product determination, the inspection conditions used for the inspection, and the like.

[0104] The camera timing control device 57 controls the imaging timing of the inspection camera 51. The imaging timing is controlled based on a signal from an encoder (not shown) provided in the PTP packaging machine 10, and the inspection camera 51 captures an image every time a predetermined amount of container film 3 is fed.

[0105] The CPU and the input / output interface 58 are responsible for various controls in the inspection devices 22 to 24. The CPU and the input / output interface 58 are configured to be able to send and receive information between the components of the PTP packaging machine 10. Thus, the above-mentioned defective sheet discharge mechanism and the like can be controlled. Furthermore, the CPU and the input / output interface 58 are configured to be able to send and receive information between the outflow risk management system 70.

[0106] The conformity determination device 52 constructed as described above at least performs conformity determination of the tablet 5 based on the image data obtained by the inspection camera 51. In the conformity determination device 52, for example, binarization processing of the image data or block processing of the binarized image data is performed, and the conformity of the tablet 5 is determined based on various information stored in the determination memory 55.

[0107] Next, the inspection items performed by the inspection devices 22 to 24 will be described in detail.

[0108] The first inspection device 22 determines whether the tablet 5 is acceptable or not for the inspection item of “tablet shape” based on the image data (brightness image data) obtained by the inspection camera 51 (see Fig. 9 ). In the acceptance judgment regarding the “shape of the tablet 5”, it is judged whether cracks or notches occur in the tablet 5, or whether the shape or size (dimensions) of the tablet 5 is suitable for the type of manufacture.

[0109] The second inspection device 23 determines whether the tablet 5 is acceptable based on the image data (color image data) obtained by the inspection camera 51, not only regarding the “tablet shape” but also regarding the “printing pattern” and “tablet color” inspection items (see Fig. 9). In the pass / fail judgment on the "printing part style", the presence or absence of the printing part 5k, the shape or color of the printing part 5k, etc. are judged. In addition, when the tablet 5 is provided with an engraving, the pass / fail judgment on the engraving style can also be performed at the same time as the pass / fail judgment on the "printing part style". In the pass / fail judgment on the "tablet color", it is judged whether the color of the tablet 5 is suitable for the manufacturing type.

[0110] The third inspection device 24 determines whether the tablet 5 is acceptable or not in the inspection item of "tablet spectrum" based on the image data (spectral image data) obtained by the inspection camera 51 (see Fig. 9 ). In the acceptance judgment of "spectrum of tablets", principal component analysis (PCA) is performed on the spectrum image data obtained by the inspection camera 51 to determine whether the composition of the tablet 5 matches the manufacturing type.

[0111] When all the inspection items of the tablet 5 are judged as qualified, the tablet 5 is judged as a qualified product; and when at least one of the inspection items is judged as unqualified, the tablet 5 is judged as an unqualified product. Moreover, when the tablet 5 is judged as an unqualified product, the PTP sheet 1 containing the unqualified tablet 5 is discharged as a unqualified product by the unqualified sheet discharge mechanism.

[0112] Next, the outflow risk management system 70 is described. The outflow risk management system 70 evaluates the risk of inappropriate tablets 5 (different type tablets) that should not be contained in the PTP sheet 1 according to the progress of sequentially manufacturing different types of PTP sheets 1, and takes measures to reduce the risk based on the evaluation.

[0113] Outflow risk management system70 Figure 5 As shown, it is provided with a display device 71, an input device 72, a progress management device 73, an inspection data management device 74, and a processing device 75. In this embodiment, the progress management device 73 constitutes a "progress management mechanism". The progress management device 73, the inspection data management device 74, and the processing device 75 are constituted by a computer system, etc., and the computer system has a CPU, ROM, RAM, and a storage medium, etc.

[0114] The display device 71 displays information stored in the outflow risk management system 70. In the present embodiment, the display device 71 displays the production progress (input progress) input by the operator or the like, or the production progress (proposed progress) suggested by the risk reduction measure execution unit 753 described later (see Fig.13). In addition, the display device 71 also displays the production progress (derived progress) derived by the progress derivation unit 731 described later, the type of PTP sheet 1 to be produced, the production progress (determined progress) selected and determined by the operator from the proposed progress, etc. However, the information displayed on the display device 71 can be appropriately changed. In addition, as described later, it is also possible to configure that the derived progress is not displayed when the production progress derivation function by the progress derivation unit 731 is invalidated.

[0115] The input device 72 is used to input information to the outflow risk management system 70. The operator or the like can input the type of PTP sheet 1 to be produced or the production schedule through the input device 72. In addition, the operator or the like can select and determine the final (in actual production use) production schedule from the proposed schedule through the input device 72. The input information is stored in the schedule management device 73.

[0116] The schedule management device 73 manages the production schedule including information related to the production sequence of the PTP sheets 1 performed by the PTP packaging machine 10. In the present embodiment, the schedule management device 73 has a storage function, which stores various production schedules such as the above-mentioned input schedule or export schedule, and the types of PTP sheets 1 to be produced. The production schedule (input schedule) input by the operator is associated with the priority set by the operator and is stored in the schedule management device 73. For example, in the production of types K1, K2 and K3 (refer to Fig.10 In the case of a PTP sheet 1 (such as a PTP sheet 1), an operator or the like inputs production schedules such as "K1→K2→K3", "K2→K1→K3", and "K1→K3→K2" together with the priority. As a result, in the schedule management device 73, for example, "K1→K2→K3" is stored as the first priority production schedule, "K2→K1→K3" is stored as the second priority production schedule, and "K1→K3→K2" is stored as the third priority production schedule.

[0117] In addition, the schedule management device 73 in this embodiment includes a schedule deriving unit 731. In this embodiment, the schedule deriving unit 731 constitutes a "schedule deriving means." The schedule deriving unit 731 uses information related to the type of the PTP sheet 1 to be produced to automatically derive the production schedule (schedule deriving step).

[0118] In more detail, the schedule management device 73 generates a plurality of tentative schedules containing information related to the production order of these PTP sheets 1, based on the types of PTP sheets 1 to be produced input by the operator or the like. For example, types K1, K2, and K3 are stored in the schedule management device 73 as the types of PTP sheets 1 to be produced. In this case, the schedule derivation unit 731 generates a total of six tentative schedules, namely, "K1→K2→K3", "K1→K3→K2", "K2→K1→K3", "K2→K3→K1", "K3→K1→K2", and "K3→K2→K1".

[0119] Then, when the PTP sheet 1 is produced according to these tentative schedules, the schedule deriving unit 731 derives at least a production schedule that can reduce the following “risk” the most from among the plurality of tentative schedules based on the evaluation results of the risk evaluation unit 752 described later. The derived production schedule is stored in the schedule management device 73.

[0120] Here, "risk" means that the PTP sheet 1 to be produced next may be mistakenly mixed with tablets 5 that are considered to be different types of tablets and contained in the PTP sheet 1 produced previously, and the PTP sheet 1 mixed with the different types of tablets may flow to a process later than the PTP packaging machine 10.

[0121] In this embodiment, as described later, when the total risk points are calculated by the risk assessment unit 752 as a comprehensive assessment of "risk", the progress derivation unit 731, based on the requirements of the operator or the like (for example, the requirements input by the input device 72), derives the progress with the smallest total risk points from a plurality of tentative progresses as the production progress that is most capable of reducing the "risk".

[0122] For example, the tablets 5 associated with the categories K1 to K3 are respectively provided with Fig.11 In the case of the shape represented by the shape data shown, the total risk point number is, for example, 40 points when the tentative schedule is "K1→K2→K3", and 10 points when the tentative schedule is "K1→K3→K2". In addition, the calculation method of the total risk point number is described later. Furthermore, the total risk point number is 30 points when the tentative schedule is "K2→K1→K3", and 10 points when the tentative schedule is "K2→K3→K1". Furthermore, the total risk point number is 30 points when the tentative schedule is "K3→K1→K2", and 20 points when the tentative schedule is "K3→K2→K1". Therefore, the schedule derivation unit 731 derives "K1→K3→K2" and "K2→K3→K1" from a plurality of tentative schedules as the production schedule that can best reduce the "risk".

[0123] In addition, the schedule deriving unit 731 may derive a production schedule in which the total risk point number is smaller than a predetermined value, in addition to deriving a production schedule in which the total risk point number is minimized.

[0124] In the present embodiment, the function of exporting the production progress by the progress exporting unit 731 can be switched between being effective and ineffective by the operation of the operator or the like. If the function of exporting the production progress is effective, the display device 71 displays the production progress input by the operator or the like (input progress) and the production progress exported by the progress exporting unit 731 (export progress) (see Fig.13 On the other hand, if the production progress export function is invalid, the progress export unit 731 does not export the production progress, and only the production progress input by the operator is displayed on the display device 71.

[0125] The inspection data management device 74 manages the inspection condition data used in the pass / fail determination of the tablet 5. The inspection data management device 74 stores the inspection condition data required for the inspection devices 22 to 24 to perform the pass / fail determination. In the present embodiment, the inspection condition data includes data IF1, IF2, ... Ifn on the shape of the tablet 5, data IM1, IM2, ... IMn on the printing unit 5k, data IC1, IC2, ... Icn on the color of the tablet 5, and data IS1, IS2, ... ISn on the spectrum of the tablet 5 (see FIG. 1 ). Fig.10 ) etc. In addition, the data IF1, IM1, IC1 and IS1 are used for determining whether the tablets 5 related to the type K1 are qualified, the data IF2, IM2, IC2 and IS2 are used for determining whether the tablets 5 related to the type K2 are qualified, and the data IF3, IM3, IC3 and IS3 are used for determining whether the tablets 5 related to the type K3 are qualified.

[0126] In addition, the inspection data management device 74 outputs data required for the inspection condition data to each inspection device 22 to 24 in accordance with the switching of the type of the PTP sheet 1. For example, when producing the PTP sheet 1 of type K1, since the first inspection device 22 determines whether the inspection item regarding the "tablet shape" is acceptable, the data IF1 regarding the shape of the tablet 5 is output to the first inspection device 22 as the inspection condition data. In each inspection device 22 to 24, the setting corresponding to the type of the PTP sheet 1 produced is performed based on the inspection condition data input from the inspection data management device 74.

[0127] Furthermore, the inspection data management device 74 stores tablet image data TP1, TP2, ... TPn and basic data PP1, PP2, ... PPn for each type K1 to Kn (see Fig.10). In the present embodiment, the tablet image data TP1 to TPn are image data of the tablet 5. The basic data PP1 to PPn represent image data of the container film 3 (including the bag portion 2) in a state where the bag portion 2 does not contain the tablet 5. In addition, the basic data PP1 to PPn may represent image data of the container film 3 in a state where the tablet 5 is contained in the bag portion 2. As the basic data PP1 to PPn and the tablet image data TP1 to TPn, the corresponding ones of the multiple image data (brightness image data, color image data, and spectral image data) obtained by each inspection camera 51 of the inspection devices 22 to 24 are respectively stored. For example, the basic data PP1 is composed of a total of three types of image data related to the type K1.

[0128] Furthermore, the inspection data management device 74 stores data on the tablets 5 and the bag 2 related to the types K1, K2 ... Kn of the PTP sheets 1 to be produced. The data on the tablets 5 include shape data TS1, TS2 ... TSn, printing data TM1, TM2 ... TMn, color data TC1, TC2 ... TCn, and spectrum data SP1, SP2 ... SPn. The data on the bag 2 include shape data PS1, PS2 ... PSn.

[0129] like Fig.11 As shown, in this embodiment, shape data TS1 indicates that the tablet is circular in plan view and has an outer diameter of 4 mm; shape data TS2 indicates that the tablet is circular in plan view and has an outer diameter of 6.5 mm; shape data TS3 indicates that the tablet is circular in plan view and has an outer diameter of 9 mm. The shape data of tablet 5 may include information about the thickness or cut line of tablet 5, for example.

[0130] Printing data TM1 indicates that the printing unit 5k is set on both sides of the tablet 5 (the surface 5b and the back side 5c), and the printed content is data A; printing data TM2 indicates that the printing unit 5k is set on a single side of the tablet 5 (the surface 5b or the back side 5c), and the printed content is data B; printing data TM3 indicates that the printing unit 5k is not set.

[0131] The color data TC1 and TC2 indicate that the tablet 5 is white, and the color data TC3 indicates that the tablet 5 is red.

[0132] The spectrum data SP1 and SP2 indicate that the spectrum data obtained when the tablet 5 is subjected to spectroscopic analysis is data Y, and the spectrum data SP3 indicates that the spectrum data obtained when the tablet 5 is subjected to spectroscopic analysis is data Z.

[0133] The shape data PS1 of the bag 2 indicates that it is circular when viewed from above, and its outer diameter (especially the outer diameter of the opening) is 5.5 mm; the shape data PS2 indicates that it is circular when viewed from above, and its outer diameter is 8 mm; the shape data PS3 indicates that it is circular when viewed from above, and its outer diameter is 10.5 mm. In addition, the shape data of the bag 2 may include, for example, the depth of the bag 2.

[0134] The processing device 75 estimates the “risk” that the PTP sheet 1 mixed with tablets of a different kind will flow out to a process later than the PTP packaging machine 10 , and executes measures for reducing the “risk” based on the evaluation result.

[0135] The processing device 75 is as follows Figure 5 As shown, it is provided with an inspection simulation execution unit 751, a risk assessment unit 752, and a risk reduction measure execution unit 753. In this embodiment, the inspection simulation execution unit 751 constitutes an "inspection simulation execution mechanism", similarly, the risk assessment unit 752 constitutes a "risk assessment mechanism", and the risk reduction measure execution unit 753 constitutes a "risk reduction measure execution mechanism".

[0136] The inspection simulation execution unit 751 performs a pass / fail determination on the inspection devices 22 to 24 that are set to perform the inspection of the tablet 5 related to the PTP sheet 1 to be produced next, based on the virtual different-type tablet image data generated using the image data of the tablet 5 related to the PTP sheet 1 produced once before the PTP sheet 1. That is, the inspection simulation execution unit 751 simulates whether the different-type tablet (the tablet 5 related to the PTP sheet 1 produced once before) can be detected by the inspection devices 22 to 24 when the PTP sheet 1 is produced according to the production schedule or the tentative schedule. Specifically, the inspection simulation execution unit 751 confirms the detection of the different-type tablet by performing the inspection simulation processing (inspection simulation execution process) as shown below.

[0137] like Fig.14 As shown, in the inspection simulation process, first, in step S11, virtual heterogeneous tablet image data is generated. The virtual heterogeneous tablet image data is generated using basic data PP1-PPn related to the PTP sheet 1 to be produced next and tablet image data TP1-TPn of tablets 5 related to the PTP sheet 1 produced once before.

[0138] More specifically, virtual heterogeneous tablet image data is generated by pasting tablet image data TP1, TP2, ... TPn to the pocket 2 region in the basic data PP1, PP2, ... PPn. For example, in the inspection simulation process in which the type K2 is produced after the type K1, virtual heterogeneous tablet image data is generated by pasting tablet image data TP1 to the pocket 2 region in the basic data PP2. In terms of the virtual heterogeneous tablet image data, inspection data assumed to be performed by the first inspection device 22, inspection data assumed to be performed by the second inspection device 23, and inspection data assumed to be performed by the third inspection device 24 are generated respectively. In addition, depending on the size of the pocket 2 region in the basic data, etc., in the virtual heterogeneous tablet image data, the tablet image data may sometimes exceed the pocket 2 region.

[0139] In addition, in the case of using image data of tablets 5 already contained in the bag 2, virtual heterogeneous tablet image data can be generated by pasting the tablet image data to the tablet 5 region in the basic data. However, in the case where the tablet 5 region in the basic data exceeds the pasted tablet image data, it is preferable to perform processing to delete the exceeding portion and return the region corresponding to the background of the tablet image data to a natural state. In terms of such processing, there can be cited processing to change the brightness value of the pixels constituting the exceeding region to the same value or a similar value as the brightness value of the pixels located around the exceeding region, or processing to expand the region located around the exceeding region, etc.

[0140] Next, in step S12, the inspection program is executed. By executing the program, first, the inspection data management device 74 outputs the required inspection condition data to each inspection device 22 to 24. Then, in the inspection devices 22 to 24, the input inspection condition data is used to perform settings for inspecting the tablet 5 related to the PTP sheet 1 to be produced next.

[0141] Furthermore, according to the execution of the inspection program, virtual different-type tablet image data is input to each of the inspection devices 22 to 24. For example, virtual different-type tablet image data assuming that the first inspection device 22 will perform inspection is input to the first inspection device 22.

[0142] Then, each inspection device 22 to 24 performs a pass / fail determination based on the virtual heterogeneous tablet image data. This pass / fail 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 .

[0143] Then, in step S13, for each inspection item, it is determined whether the received qualification determination result is a qualified determination. In the case where the determination in step S13 is no, that is, in a certain inspection item, all of the heterogeneous tablets (the pasted tablet image data) are determined to be unqualified products, the inspection simulation execution unit 751 regards the final determination result of the inspection item by the inspection simulation processing as "detectable" and ends the inspection simulation processing. On the other hand, in the case where the determination in step S13 is yes, that is, in a certain inspection item, at least one of the heterogeneous tablets is determined to be a qualified product, the inspection simulation execution unit 751 performs the risk avoidance processing of step S14 as needed.

[0144] In the risk avoidance process, after the inspection condition data (e.g., threshold value, etc.) about the inspection items that meet the requirements stored in the inspection data management device 74 is changed, the inspection program is executed again (step S12). That is, after the inspection condition data is changed so that the inspection accuracy becomes higher, for example, the inspection devices 22 to 24 are made to perform the pass / fail determination on the inspection items that meet the requirements using the inspection condition data. In addition, when the actual tablets 5 are inspected by the inspection devices 22 to 24, in order to avoid excessive occurrence of the case where the qualified tablets 5 are mistakenly determined as unqualified, the changeable range of the inspection condition data is determined in advance.

[0145] The inspection simulation execution unit 751 repeatedly changes the inspection condition data and causes the inspection devices 22 to 24 to use the changed inspection condition data to perform qualification determination until all heterogeneous tablets that meet the inspection items are determined to be unqualified, or until the inspection condition data is changed to the limit of the changeable range.

[0146] Finally, if all heterogeneous tablets are judged as defective in the corresponding inspection items, the inspection simulation execution unit 751 regards the final judgment result of the inspection item by the inspection simulation process as "detectable" and ends the inspection simulation process. The inspection data management device 74 stores the changed inspection condition data.

[0147] On the other hand, even if the inspection condition data has been changed to the limit of the changeable range, if at least one of the heterogeneous tablets is judged to be a qualified product in the corresponding inspection item, the inspection simulation execution unit 751 will regard the final judgment result of the inspection item processed by the inspection simulation as "undetectable" and end the inspection simulation processing.

[0148] Furthermore, the inspection simulation execution unit 751 may cause the inspection devices 22 to 24 to perform the pass / fail determination on only a portion of the above-mentioned multiple inspection items. For example, the inspection device 23 may perform the pass / fail determination on only the shape of the tablet 5 .

[0149] When producing the PTP sheet 1 according to the production schedule, the risk assessment unit 752 assesses the "risk", which is the risk that the tablet 5 regarded as a different type of tablet contained in the PTP sheet 1 produced previously by the PTP sheet 1 is mistakenly mixed into the PTP sheet 1 to be produced next, and the PTP sheet 1 mixed with the different type of tablet flows to a process later than the PTP packaging machine 10. In the present embodiment, the risk assessment unit 752 has: a function of assessing the "risk" related to the production schedule (input schedule and output schedule), which is input by an operator or the like, or is output by the schedule output unit 731; and a function of assessing the "risk" related to the provisional schedule, which is generated by the schedule output unit 731. The step of assessing the "risk" by the risk assessment unit 752 is equivalent to the "risk assessment step".

[0150] The risk assessment unit 752 assesses the "risk" of the inspection items (in this embodiment, the shape, color, printing, and spectrum of the tablet 5) of the inspection devices 22 to 24. That is, if the risk assessment unit 752 can detect the different type of tablet as a defective product at a certain inspection item even if a different type of tablet is mixed into the PTP sheet 1 to be produced next, the "risk" of the inspection item is low. On the other hand, if the risk assessment unit 752 cannot detect the different type of tablet as a defective product at a certain inspection item when a different type of tablet is mixed into the PTP sheet 1 to be produced next, the "risk" of the inspection item is high. In addition, the risk assessment unit 752 can grasp the inspection items of the tablet 5 by the inspection devices 22 to 24 by using the inspection condition data stored in the inspection data management device 74.

[0151] Furthermore, the risk assessment unit 752 assesses the "risk" based on the pass / fail determination result when the inspection simulation execution unit 751 performs the pass / fail determination on the inspection devices 22 to 24 based on the virtual heterogeneous tablet image data. That is, the risk assessment unit 752 assesses the "risk" based on the final determination result of the inspection simulation process.

[0152] Here, the method of evaluating "risk" performed by the risk evaluation unit 752 will be described in more detail.

[0153] The risk assessment unit 752 assesses the "risk" of the shape of the tablet 5 based on the pass / fail judgment of the shape of the tablet 5 by the inspection devices 22 and 23. That is, the risk assessment unit 752 performs an inspection simulation process to confirm the final judgment result of the inspection item regarding the shape. Then, if the judgment result of the risk assessment unit 752 is "detectable", the "risk" of the shape of the tablet 5 is evaluated as low; if the judgment result is "undetectable", the "risk" of the shape of the tablet 5 is evaluated as high.

[0154] 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 very different (for example, the outer diameters of each tablet differ by more than 1.0 mm). Therefore, when the type K2 is to be produced after the type K1, the final judgment result of the inspection item about the shape by the inspection simulation process becomes "detectable". Therefore, the risk assessment unit 752 assesses the shape of the tablet 5 as having a low "risk" when the type K2 is to be produced after the type K1.

[0155] On the other hand, for example, Fig.12 As shown in the 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 assumed to be the same. In this case, when the type K2 is to be produced after the type K1, the final judgment result of the inspection item about the shape by the inspection simulation processing becomes "undetectable". Therefore, when the type K2' is to be produced after the type K1, the risk assessment unit 752 assesses the shape of the tablet 5 as "high risk".

[0156] Furthermore, the risk assessment unit 752 assesses the "risk" of the printing unit 5k based on the qualification determination of the printing unit 5k by the inspection device 23. The "risk" assessment is also performed based on the determination result of the inspection simulation process as described above. That is, the risk assessment unit 752 performs the inspection simulation process to confirm the final determination result of the inspection item regarding printing. Then, if the determination result of the risk assessment unit 752 is "detectable", the "risk" at this point of the printing unit 5k is assessed as low; if the determination result is "undetectable", the "risk" at this point of the printing unit 5k is assessed as high.

[0157] For example, the printing data TM1 of the tablet 5 related to the type K1 and the printing data TM2 of the tablet 5 related to the type K2 are very different in the surface where the printing unit 5k is set or the printing content. Therefore, when the type K2 is to be produced after the type K1, the final judgment result of the inspection item about printing by the inspection simulation process becomes "detectable". Therefore, the risk assessment unit 752 assesses that the "risk" is low in the printing unit 5k when the type K2 is to be produced after the type K1.

[0158] In addition, the risk assessment unit 752 assesses the "risk" of the color of the tablet 5 based on the pass / fail judgment of the color of the tablet 5 by the inspection device 23. The "risk" assessment is also performed based on the judgment result of the inspection simulation process as described above. That is, the risk assessment unit 752 performs the inspection simulation process to confirm the final judgment result of the inspection item regarding the color of the tablet 5. And, if the judgment result of the risk assessment unit 752 is "detectable", the "risk" of the color of the tablet 5 is assessed as low; if the judgment result is "undetectable", the "risk" of the color of the tablet 5 is assessed as high.

[0159] For example, the color data TC1 of the tablet 5 related to the type K1 and the color data TC2 of the tablet 5 related to the type K2 each indicate that the tablet 5 is white, and there is no significant difference between the two data TC1 and TC2. Therefore, when the type K2 is to be produced after the type K1, the final judgment result of the inspection item about the color of the tablet 5 by the inspection simulation processing becomes "undetectable". Therefore, the risk assessment unit 752 assesses the color of the tablet 5 as "high risk" when the type K2 is to be produced after the type K1.

[0160] At the same time, the risk assessment unit 752 evaluates the "risk" of the spectrum of the tablet 5 based on the qualification judgment of the spectrum (component) of the tablet 5 by the inspection device 24. The evaluation of this "risk" is also performed based on the judgment result of the inspection simulation process as described above. That is, the risk assessment unit 752 performs the inspection simulation process to confirm the final judgment result of the inspection item of the spectrum of the tablet 5. Then, if the judgment result of the risk assessment unit 752 is "detectable", the "risk" is evaluated as low at this point of the spectrum (component) of the tablet 5; if the judgment result is "undetectable", the "risk" is evaluated as high at this point of the spectrum of the tablet 5.

[0161] For example, the spectral data SP1 of the tablet 5 related to the type K1 and the spectral data SP2 of the tablet 5 related to the type K2 are each data Y, and there is no significant difference between the two data SP1 and SP2. Therefore, when the type K2 is to be produced after the type K1, the final judgment result of the inspection item about the spectrum of the tablet 5 by the inspection simulation processing becomes "undetectable". Therefore, the risk assessment unit 752 assesses the spectrum of the tablet 5 as "high risk" when the type K2 is to be produced after the type K1.

[0162] Furthermore, the risk assessment unit 752 not only assesses the "risk" according to the inspection items, but also assesses the "risk" as follows. That is, the risk assessment unit 752 assesses the "risk" according to the size of the bag portion 2 of the PTP sheet 1 to be produced next (referred to as "bag size") and the size of the tablets 5 contained in the PTP sheet 1 produced once before the PTP sheet 1 (referred to as "tablet size").

[0163] In this embodiment, the risk assessment unit 752 assesses that the “risk” is low when the bag size is smaller than the tablet size and the tablet 5 related to the PTP sheet 1 produced once previously cannot be physically accommodated in the bag portion 2 of the PTP sheet 1 to be produced next. On the other hand, the risk assessment unit 752 assesses that the “risk” is high when the bag size is larger than the tablet size and the tablet 5 related to the PTP sheet 1 produced once previously can be accommodated in the bag portion 2 of the PTP sheet 1 to be produced next.

[0164] For example, since the size of the bag associated with type K2 is larger than the size of the tablet associated with type K1, when type K2 is to be produced after type K1, the tablet 5 associated with type K1 can be physically contained in the bag portion 2 associated with type K2. Therefore, the risk assessment unit 752 assesses the comparison of the size of the tablet 5 and the bag portion 2 as high "risk".

[0165] The risk assessment unit 752 performs the above-mentioned "risk" assessment each time the type of production schedule or provisional schedule is switched. For example, when the production schedule is "K1→K2→K3", the risk assessment unit 752 assesses the "risk" when switching from type K1 to type K2 and the "risk" when switching from type K2 to type K3.

[0166] The risk assessment unit 752 assigns points according to the assessed “risk.” In this embodiment, the risk assessment unit 752 sets the risk point to 0 if the assessed “risk” is low, and sets the risk point to 10 if the assessed “risk” is high.

[0167] For example, the production schedule is set to "K1 → K2 → K3". In this case, if you want to switch from type K1 to type K2, Fig.15 As shown, the risk points are 0 points for the shape of the tablet 5 (a1), 0 points for the printed portion 5k (b1), 10 points for the color of the tablet 5 (c1), 10 points for the spectrum of the tablet 5 (d1), and 10 points for the size comparison between the tablet 5 and the bag portion 2 (e1).

[0168] Furthermore, if you want to switch from type K2 to type K3, Fig.16As shown, the risk points are 0 points for the shape of the tablet 5 (a2), 0 points for the printed portion 5k (b2), 0 points for the color of the tablet 5 (c2), 0 points for the spectrum of the tablet 5 (d2), and 10 points for the size comparison between the tablet 5 and the bag portion 2 (e2).

[0169] Furthermore, the risk assessment unit 752 finally calculates the total number of risk points (total risk points). For example, in the above example, it is 40 points. Based on the calculated total risk points, as described above, the schedule derivation unit 731 derives the production schedule that can best reduce the "risk" from multiple tentative schedules. Furthermore, based on the calculated total risk points, the following measures are implemented by the risk reduction measure execution unit 753.

[0170] The risk reduction measure execution unit 753 executes a measure for reducing the “risk” based on the evaluation result of the risk evaluation unit 752. The step of executing the measure by the risk reduction measure execution unit 753 corresponds to the “risk reduction measure execution step”.

[0171] In the present embodiment, based on the requirements of operators and the like (for example, requirements inputted by the input device 72), the risk assessment unit 752 assesses the "risk" associated with the production schedule (input schedule) inputted by the operators and the like and the production schedule (derived schedule) derived by the schedule derivation unit 731. Furthermore, the risk reduction measure execution unit 753 determines the production schedule with at least the lowest total risk points from the input schedule and the derived schedule as the proposed schedule. Then, the risk reduction measure execution unit 753 stores the determined proposed schedule in the schedule management device 73, and prompts the operators and the like using the display device 71. Therefore, the risk reduction measure execution unit 753 can execute measures using the production schedule derived by the schedule derivation unit 731 as measures to reduce the "risk".

[0172] In addition, when there are multiple production schedules with the lowest total risk points, the risk reduction measure execution unit 753 gives priority to presenting a schedule that is consistent with the production schedule (input schedule) input by the operator, etc., among the production schedules with the lowest total risk points. In addition, the risk reduction measure execution unit 753 may be configured to present multiple production schedules with a total risk point of less than a fixed number, for example.

[0173] In addition, when the production progress export function of the progress export unit 731 is invalidated, the risk reduction measure execution unit 753 prompts at least the production progress with the lowest total risk points from the production progress (input progress) input by the operator, etc. as a proposed progress.

[0174] The operator or the like can select and determine the production schedule to be used in actual production from the production schedules (proposed schedules) presented using the input device 72. 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, the production of the PTP sheet 1 is carried out according to the determined production schedule. In addition, when producing the PTP sheet 1, the inspection condition data changed in the above-mentioned risk avoidance process (step S14) is used as necessary.

[0175] Furthermore, when the total risk point number in the production schedule with the lowest total risk point number is higher than the preset reference point number, the risk reduction measure execution unit 753 may also take measures to urge the cleaning of the PTP packaging machine 10 performed when the type of the PTP sheet 1 is switched to ensure a longer cleaning time, in addition to or instead of the production schedule prompt. Furthermore, in addition to or instead of the production schedule prompt, measures to urge the change of the input production schedule may be taken using an alarm or the like. Of course, measures other than these may also be executed.

[0176] As described in detail above, according to the present embodiment, the risk of the PTP sheet 1 (heterogeneous tablet container) mixed with heterogeneous tablets flowing out to a process later than the PTP packaging machine 10 can be evaluated by the risk assessment unit 752 by utilizing the production progress of the PTP sheet 1. Furthermore, based on the evaluation result of the risk assessment unit 752, the risk reduction measure execution unit 753 can execute measures for reducing the "risk". Since the production progress of the PTP sheet 1 is utilized in this way, the risk of the heterogeneous tablet container flowing out can be more effectively reduced compared to detecting the composition of heterogeneous tablets only by inspecting the tablets 5.

[0177] Furthermore, the risk assessment unit 752 assesses the “risk” that a tablet that is considered to be a different type of tablet and is contained in a PTP sheet 1 produced once before the PTP sheet 1 is mistakenly mixed into the PTP sheet 1 to be produced next, and the PTP sheet mixed with the different type of tablet flows out to a later process than the container production device. Therefore, the risk assessment unit 752 does not assess the “risk” associated with the following event, which is that a tablet that is considered to be a different type of tablet and is contained in a PTP sheet 1 produced twice or more before the PTP sheet 1 is mistakenly mixed into the PTP sheet 1 to be produced next. Therefore, the processing burden associated with risk assessment can be reduced.

[0178] Furthermore, the risk assessment unit 752 assesses the “risk” based on the inspection items of the tablet 5 by the inspection devices 22 to 24. Therefore, the “risk” can be appropriately and easily assessed.

[0179] In addition, the risk assessment unit 752 assesses the "risk" based on the pass / fail judgment result, which is the result of the pass / fail judgment performed by the inspection simulation execution unit 751 on the inspection devices 22 to 24 using the virtual heterogeneous tablet image data. Therefore, without actually performing the pass / fail judgment of the tablet 5 by the inspection devices 22 to 24, it is possible to confirm in advance whether the heterogeneous tablet is properly detected (the heterogeneous tablet is judged to be unqualified) as the result of the pass / fail judgment by the inspection devices 22 to 24. Thus, the "risk" can be assessed more appropriately.

[0180] Meanwhile, the risk assessment unit 752 assesses the “risk” based on the size (bag size) of the bag portion 2 of the PTP sheet 1 to be produced next and the size (tablet size) of the tablet 5 related to the PTP sheet 1 produced once before the PTP sheet 1. Therefore, the “risk” can be assessed more appropriately.

[0181] Furthermore, the progress exporting unit 731 can automatically export a production progress with low "risk", and the risk reduction measure executing unit 753 can take measures to utilize the exported production progress (e.g., prompt the exported production progress, etc.). Therefore, the "risk" can be further reduced.

[0182] Furthermore, since the production schedule can be automatically derived by the schedule derivation unit 731, it is not necessary for the operator to prepare the production schedule. Therefore, the convenience can be improved. For example, in the present embodiment, when the operator only inputs the type of the PTP sheet 1 to be produced, the schedule derivation unit 731 can automatically derive a production schedule with low "risk", and the risk reduction measure execution unit 753 can prompt the operator with the derived production schedule as a proposed schedule. In this case, it is also possible to directly prompt the derived schedule as the proposed schedule without evaluating the "risk" for determining the proposed schedule from the input schedule or the derived schedule.

[0183] In addition, the present invention is not limited to the contents of the above-mentioned embodiments, and may be implemented in the following manner, for example. Of course, other application examples and modification examples not shown below are also possible.

[0184] (a) In the above-mentioned embodiment, the production progress (proposed progress) suggested by the risk reduction measure execution unit 753 or the production progress (derived progress) derived by the progress derivation unit 731 is determined based on the total risk points, but it may also be determined based on other indicators.

[0185] For example, in the production schedule (input schedule, etc.) or the tentative schedule, the total number of risk points when the type of the PTP sheet 1 is switched once may be calculated according to the switching type, and then the proposed schedule or the derived schedule may be determined based on the calculated multiple total points. In this case, the maximum value of the calculated multiple total points may be determined as the proposed schedule or the derived schedule with the lowest production schedule or the tentative schedule.

[0186] To be more specific, Fig.11 In the example shown, when the production schedule (input schedule, etc.) or the tentative schedule is "K1→K2→K3", the total number of risk points associated with the first type switching (first total number of points) is 30 points, and the total number of risk points associated with the second type switching (second total number of points) is 10 points. In contrast, in a certain production schedule X (tentative schedule X), the first total number of points and the second total number of points are assumed to be 20 points, respectively. In this case, the latter production schedule X (tentative schedule X) with a smaller maximum value may be regarded as the proposed schedule or the derived schedule.

[0187] The above-mentioned numerical values ​​of the risk points (0 points or 10 points) are shown as examples, and the numerical values ​​may be changed as appropriate. Of course, the risk points may be changed according to each item used in the evaluation of "risk". For example, the following configuration may be adopted, that is, if the "risk" is high in the shape of the tablet 5, the risk points are set to 10 points, and on the other hand, if the "risk" is high in the printing part 5k, the risk points are set to 5 points.

[0188] Furthermore, in the above embodiment, the risk score is divided into two stages, but it can also be divided into three or more stages. That is, the assessment of "risk" is not carried out in two stages of high and low, but in three or more stages.

[0189] Furthermore, the following configuration may be adopted, that is, when a tablet of a different type can be detected as a defective product by a single inspection item or by comparison of the sizes of the tablet 5 and the bag portion 2, the “risk” associated with the type switching is evaluated as low. On the other hand, when it is not the case, the “risk” associated with the type switching is evaluated as high. For example, in the above-mentioned embodiment, when type K2 is to be produced after type K1, because a tablet of a different type can be detected as a defective product by an inspection item of shape or printing, even if a tablet of a different type cannot be detected as a defective product by an inspection item such as color, the “risk” associated with the type switching can be evaluated as low.

[0190] (b) In the above embodiment, the inspection simulation execution unit 751 is used to evaluate the "risk" according to the inspection items. However, it is not always necessary to use the inspection simulation execution unit 751.

[0191] Therefore, it is also possible to construct a system to evaluate the "risk" according to the inspection item by comparing various data related to the shapes, printing parts 5k, colors, and spectra associated with the tablets 5 related to the PTP sheet 1 produced previously and the tablets 5 related to the PTP sheet 1 to be produced next (for example, shape data TS1, TS2, etc. stored in the inspection data management device 74).

[0192] (c) In the above embodiment, the outflow risk management system 70 includes a schedule deriving unit 731 that automatically derives the production schedule, but there may be a case where the schedule deriving unit 731 is not provided. In this case, the outflow risk management system 70 evaluates the "risk" using only the production schedule input by the operator, etc., and executes measures for reducing the "risk" based on the evaluation result.

[0193] (d) In the above embodiment, the PTP sheet 1 is cited as the "tablet container", but the tablet container is not limited to the PTP sheet 1. Therefore, the tablet container may be a blister sheet other than the PTP sheet 1, or a bottle containing tablets 5, etc.

[0194] In the case where the tablet container is a bottle as described above, the container production device for producing the bottle may also include: a conveying mechanism that conveys the tablet 5 (for example, a suction belt that conveys the tablet 5 while adsorbing it); a camera mechanism that photographs the conveyed tablet 5 to obtain image data; an inspection mechanism that makes a determination on whether the tablet 5 is qualified based on the image data obtained by the camera mechanism; and a storage mechanism that stores the inspected tablet 5 in the bottle. Of course, the container production device may also include a printing mechanism as needed, which is used to set a printing unit 5k for the tablet 5. When using such a container production device, the risk assessment unit 752 can assess the "risk" based on the inspection items of the tablet 5 by the inspection mechanism, and the risk reduction measure execution unit 753 can take measures to reduce the "risk" based on the assessment results.

[0195] Furthermore, when the tablet container is a bottle as described above, virtual different-type tablet image data can be generated by pasting tablet image data on background image data (eg, image data of a conveying mechanism acquired by an imaging device) serving as basic data.

[0196] (e) In this embodiment, the outflow risk management system 70 is configured to correspond to one PTP packaging machine 10. Alternatively, the outflow risk management system 70 may correspond to a plurality of PTP packaging machines 10. In this case, the outflow risk management system 70 evaluates the “risk” for each PTP packaging machine 10 in accordance with the settings of each PTP packaging machine 10 (e.g., the inspection items of the tablets 5).

[0197] (f) There is no particular limitation on the number and arrangement positions of the inspection devices provided in the PTP packaging machine 10. Therefore, for example, inspection devices corresponding to the conveyance path of the PTP film 6 may be provided.

[0198] Furthermore, in the above-mentioned embodiment, the inspection items of the tablets 5 in the PTP packaging machine 10 are set to the shape, the printing portion 5k, the color, and the spectrum, but the inspection items of the tablets 5 in the PTP packaging machine 10 are not limited to these.

[0199] Therefore, for example, the PTP packaging machine 10 may include one inspection device, and the inspection device may only perform acceptance determination regarding the shape of the tablet 5. In this case, the outflow risk management system 70 may evaluate the “risk” focusing on the shape of the tablet 5.

[0200] Furthermore, the PTP packaging machine 10 may not be equipped with an inspection device and may not perform the qualification determination of the tablets 5. In this case, the "risk" can be evaluated based on the size (bag size) of the bag portion 2 of the PTP sheet 1 to be produced next and the size (tablet size) of the tablet 5 related to the PTP sheet 1 produced once before the PTP sheet 1, so that the "risk" can be evaluated even if the PTP packaging machine 10 is not equipped with an inspection device.

[0201] (g) In the above embodiment, a disc-shaped tablet 5 is shown as a circle when viewed from above, but the shape of the tablet is not limited to a circle when viewed from above. Therefore, the tablet may be, for example, a polygon when viewed from above, an ellipse when viewed from above, an oblong shape when viewed from above, etc.

[0202] Tablets include not only medicines but also diet tablets, etc. Tablets include not only bare tablets but also sugar-coated tablets, film-coated tablets, chewable tablets, enteric-coated tablets, gelatin-coated tablets, capsule tablets, etc.

[0203] Explanation of symbols

[0204] 1…PTP sheet (tablet container, blister sheet), 2…bag portion, 3…container film, 5…tablet, 10…PTP packaging machine (container production device), 22…first inspection device (inspection mechanism), 23…second inspection device (inspection mechanism), 24…third inspection device (inspection mechanism), 51…inspection camera (camera mechanism), 70…risk management system for outflow of heterogeneous tablets, 73…progress management device (progress management mechanism), 100…container production system, 731…progress export unit (progress export mechanism), 751…inspection simulation execution unit (inspection simulation execution mechanism), 752…risk assessment unit (risk assessment mechanism), 753…risk reduction measures execution unit (risk reduction measures execution mechanism).

Claims

1. A risk management system for outflow of tablets of different types, which is applied to a container production device, wherein the container production device can switch the types of tablets to be contained, and each time the type is switched, tablet containers containing different tablets can be produced in sequence, wherein the device is characterized in that: The aforementioned heterogeneous tablet outflow risk management system has the following features: a progress management unit that manages a production progress including information related to a production sequence of the tablet containers by the container production device; a risk assessment unit that assesses a risk when the tablet containers are produced according to the production schedule, wherein the risk is that tablets that are regarded as tablets of a different type and are contained in the tablet containers produced once before the tablet containers are mistakenly mixed into the tablet containers to be produced next, and the tablet containers containing the tablets of a different type flow out to a process later than the container production device; and A risk reduction measures execution agency can execute measures for reducing the aforementioned risks based on the assessment results of the aforementioned risk assessment agency.

2. The heterogeneous tablet outflow risk management system according to claim 1, characterized in that: The container production device has an inspection mechanism that determines whether the tablets are acceptable. The risk assessment unit is configured to assess the risk based on inspection items of the tablet performed by the inspection unit.

3. The heterogeneous tablet outflow risk management system according to claim 2, characterized in that: The aforementioned inspection items include at least one of the color, shape, printing, engraving and spectrum of the tablet.

4. The heterogeneous tablet outflow risk management system according to claim 2, characterized in that: The aforementioned container production device has a camera mechanism for photographing the tablets; The inspection mechanism is configured to make a determination on whether the tablet is acceptable based on the image data obtained by the imaging mechanism; An inspection simulation executing means is provided for executing a pass / fail determination on the inspection means set to inspect tablets associated with the tablet container to be produced next, based on virtual tablet image data of a different type, the virtual tablet image data of a different type being generated using image data of tablets associated with the tablet container produced once before the tablet container; The risk assessment unit is configured to assess the risk based on a conformity determination result, wherein the conformity determination result is a result of the inspection simulation execution unit executing a conformity determination on the inspection unit based on the virtual heterogeneous tablet image data.

5. The heterogeneous tablet outflow risk management system according to claim 1, characterized in that: The tablet container is a blister sheet formed by accommodating the tablets in a pocket formed by a container film; The risk assessment unit is configured to assess the risk based on the size of the pockets of the blister sheet to be produced next and the size of tablets contained in the blister sheet produced once before the blister sheet.

6. The heterogeneous tablet outflow risk management system according to claim 1, characterized in that: A schedule deriving means is provided, the schedule deriving means being configured to generate a plurality of tentative schedules including information on a production order of the tablet containers based on information on the plurality of tablet containers scheduled to be produced, and to derive at least the production schedule that can best reduce the risk from the plurality of tentative schedules based on an evaluation result of the risk evaluation means when the tablet containers are produced according to the tentative schedules; The risk reduction measure execution unit is configured to execute, as a measure for reducing the risk, a measure using the production schedule derived by the schedule deriving unit.

7. A container production system, comprising: The heterogeneous tablet outflow risk management system according to claim 1; and The aforementioned container production device.

8. A method for managing the risk of outflow of tablets of different types, which is applied to a container production device, wherein the container production device can switch the types of tablets to be contained, and each time the type is switched, tablet containers containing different tablets are produced in sequence, wherein: The aforementioned risk management methods for outflow of heterogeneous tablets include: a risk assessment step of assessing a risk when the tablet containers are produced according to a production schedule, the production schedule including information related to a production sequence of the tablet containers by the container production apparatus, the risk being that tablets regarded as tablets of a different type contained in the tablet container produced once before the tablet container are mistakenly mixed into the tablet container to be produced next, and the tablet container mixed with the tablets of the different type flows to a process later than the container production apparatus; and The risk reduction measure execution step executes a measure for reducing the aforementioned risk according to the evaluation result of the aforementioned risk evaluation step.

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