PHARMACEUTICAL PRODUCTION PLANT INCLUDING A MEASURING DEVICE

Description

[0001] The invention relates to a pharmaceutical production plant with a measuring device for monitoring a sealing of capsules, wherein the capsules have a capsule shell which is formed by a first shell part and a second shell part, wherein the shell parts are provided with a sealing liquid in a sealing area.

[0002] For example, a capsule filling and sealing device is known from US 2005 / 0217207 A1. This device comprises a filling unit for filling open shell parts of the capsules and a sealing unit for sealing two shell parts of the capsules that are to be connected to each other. Capsule parts to be filled or capsules to be sealed pass through the aforementioned units. The sealing unit comprises a line sensor camera for checking the sealing status of the connecting sections of the sealed capsules, combined with the purpose of sorting out capsules with faulty seals.

[0003] The device known from US 2005 / 0217207 A1 makes it possible to create a two-dimensional image of a capsule using a line sensor camera and to use this image to check the capsule's sealing status. The line sensor camera is suitable for bandings that differ significantly in color from neighboring capsule sections.

[0004] Based on this, the present invention is based on the object of enabling a more flexible detection of a sealing state.

[0005] This object is achieved in a pharmaceutical production plant of the type mentioned above in that the measuring device comprises an infrared camera or a camera with an infrared filter, wherein the measuring device detects a temperature or a temperature change of the sealing area and / or of capsule sections adjacent to the sealing area.

[0006] An infrared camera or a camera with an infrared filter enables the detection of infrared radiation and an image recording of the temperature of at least a portion of a capsule.

[0007] According to the invention, it was recognized that the application and drying of a sealing liquid are accompanied by temperature changes that are characteristic of different sealing states of a capsule. For example, the application of a still-flowing and warm sealing liquid is initially accompanied by heat input into the sealing area. Such heat input can be captured by the infrared camera or the camera with an infrared filter.

[0008] During the subsequent drying of the sealing liquid, the solvent in the sealing liquid evaporates, removing heat from the sealing liquid. Such heat dissipation can be detected by the infrared camera or a camera with an infrared filter, for example, by detecting the cooling of a capsule section and / or by detecting a change in the ambient temperature of the capsule.

[0009] The production system according to the invention enables simple and reliable detection of the sealing state of a capsule and the drying state of a sealing liquid, without requiring color differentiation of the sealing liquid and adjacent capsule sections. Furthermore, it is possible to determine the position, orientation, and spatial extent of a sealing liquid by means of image-based temperature detection.

[0010] The sealing liquid is preferably made of the same material as the capsule, for example, gelatin. The sealing liquid may be a banding liquid (in this case, the seal has a banding or is formed by a banding).

[0011] In an advantageous embodiment, the pharmaceutical production plant comprises an evaluation unit, wherein the evaluation unit is designed to automatically evaluate the temperatures and / or temperature changes detected by the measuring device. This enables at least largely automated testing of the capsules with regard to a desired sealing condition. For example, capsules with defective seals can be identified and ideally automatically sorted out.

[0012] It is further advantageous if the pharmaceutical production plant comprises a sealing device for sealing the capsules and a control unit which specifies process parameters, in particular regarding the duration and / or quantity and / or position of the application of the sealing liquid to a capsule.

[0013] In an advantageous embodiment, the sealing device is designed to apply a sealing liquid over a sealing area of ​​the capsule shell, for example, in a state in which the first shell part and the second shell part are already joined together. In this way, a tight seal in the form of a banding can be created.

[0014] In an additional or alternative embodiment, the sealing device is designed to apply a sealing liquid to a sealing region of an inner or outer surface of a casing part that has not yet been joined to another casing part, wherein the casing parts are joined to one another after application of the sealing liquid.

[0015] The control unit makes it possible to optimize the application of a sealing liquid, taking into account the type of sealing and the material properties of the capsule and the sealing liquid.

[0016] The pharmaceutical production plant preferably comprises a sealing device, a control unit, and a measuring device. This enables the production and testing of a capsule seal using a compact production unit.

[0017] The pharmaceutical production plant preferably includes a filling device. This allows capsule shells to be filled with powdered or liquid active ingredients and then sealed in the sealing device or a sealing device, with the measuring device enabling a final inspection of the sealing condition.

[0018] It is particularly preferred that the control unit communicate with the evaluation unit. The temperature state of a sealing area of ​​a capsule shell is recorded by the measuring device, and an infrared image is created. This infrared image is evaluated by the evaluation unit. The evaluation unit preferably compares the recorded actual values ​​with the target values ​​stored in the evaluation unit. Depending on such a comparison, the evaluation unit can specify modified values ​​for process parameters to the control unit.

[0019] In a further preferred embodiment, the measuring device is arranged above the sealing device relative to the direction of gravity. This allows monitoring of the sealing condition during the application of a sealing liquid or directly after the creation of a seal, without requiring additional installation space.

[0020] The pharmaceutical production plant preferably comprises a drying section along which the capsules are transported while the sealing liquid is drying. For example, it is possible for several capsules to be distributed along the drying section, with the degree of dryness of the capsules increasing along the drying section and in the transport direction of the capsules.

[0021] In particular, a plurality of measuring devices arranged spatially offset from one another is provided, wherein the measuring devices each have an infrared camera or a camera with an infrared filter. For example, a first measuring device is arranged above a sealing device with respect to the direction of gravity. A second measuring device is arranged, for example, in an area adjacent to the sealing device. If the pharmaceutical production plant comprises a drying section, a first measuring device can be provided which is spatially assigned to the sealing device and monitors the application of a sealing liquid, and a second measuring device which is spatially assigned to the drying section and monitors the drying process. The use of third and additional measuring devices is also possible.

[0022] The object mentioned above is also achieved by a method having the features of the independent method claim. Embodiments and advantages of the method according to the invention have already been explained above with reference to the production plant according to the invention.

[0023] Advantageous embodiments of the method according to the invention are the subject of subclaims 9 and 10.

[0024] Further features and advantages of the invention are the subject of the following description and the drawings of exemplary embodiments.

[0025] The drawing shows Fig. 1 is a side view of an embodiment of a pharmaceutical production plant with two measuring devices; and Fig. 2 is a top view of a first embodiment of a capsule; Fig. 3 is a top view of a further embodiment of a capsule; Fig. 4 is a pictorial representation of a capsule measured by means of a first measuring device of the production plant according to Fig. 1 detected temperature state of a plurality of capsules and their seals; and Fig. 5 one of the Fig. 4 corresponding representation of a second measuring device of the production plant according to Fig. 1 recorded temperature state of the majority of capsules and their seals.

[0026] In Fig. 1 1 schematically illustrates an embodiment of a pharmaceutical production plant, designated overall by reference numeral 10. The pharmaceutical production plant 10 is assigned a production direction 12, along which capsule parts or capsules are processed and machined. Viewed along the production direction 12, the pharmaceutical production plant 10 comprises a conveyor belt 14, a sealing device 16, and a drying section 18.

[0027] The conveyor belt 14 serves to arrange and transport casing parts 44 and 46 along the production direction 12 into the sealing device 16.

[0028] In the sealing device 16, the shell parts 44 and 46 are sealed in a sealing area 24 by means of a sealing liquid 22 to produce capsules 20 (see Fig. 2 und 3 ).

[0029] The sealing device 16 communicates with a control unit 26, which specifies process parameters for the duration and / or quantity and / or position of the application of the sealing liquid 22 to a capsule 20. For example, the sealing device 16 can be electrically connected to the control unit 26, or they can communicate wirelessly with each other.

[0030] After application of the sealing liquid 22, the sealed capsules 20 reach the drying section 18, along which the capsules 20 are transported following the production direction 12 and along which the sealing liquid 22 applied to each capsule 20 dries.

[0031] The production plant 10 has, for example, two measuring devices 30 and 32. A first measuring device 30 is preferably arranged above the sealing device 16 with respect to a direction of gravity 28. A second measuring device 32 is arranged, for example, above the drying section 18 with respect to the direction of gravity 28, in particular in the region of one end of the drying section 18.

[0032] The measuring devices 30, 32 each comprise an infrared camera 34. The measuring devices 30, 32 use the infrared camera 34 to detect temperatures and / or temperature changes of the capsules 20, in particular temperatures of the sealing areas 24 of the capsules 20.

[0033] The first measuring device 30 (associated with the sealing device 16) detects temperature states of the respective sealing areas 24 of respective capsules 20 and / or of capsule sections adjacent to a respective sealing area 24, in particular the mutually opposite ends of the shell parts 44 and 46. Fig. 4 shows an example of a pictorial representation of temperature conditions which are recorded by the first measuring device 30. Immediately following the application of the sealing liquid 22, the sealing area 24 of a capsule 20 has a significantly higher temperature than the laterally adjacent capsule sections of the shell parts 44 and 46 of this capsule 20, which in Fig. 4 corresponds to a clear contrast between the mentioned areas of the capsules 20.

[0034] The second measuring device 32 (assigned to one end of the drying section 18) also detects temperature states of the respective sealing areas 24 of respective capsules 20 and / or of capsule sections adjacent to a respective sealing area 24, in particular the mutually opposite ends of the shell parts 44 and 46. Fig. 5 shows, by way of example, a pictorial representation of temperature conditions which are recorded by the second measuring device 32. After at least largely completed drying (with evaporation of a solvent) of the sealing liquid 22 of a capsule 20, the sealing area 24 has a temperature which has largely equalized to the temperature of the laterally adjacent capsule sections of the shell parts 44 and 46 of this capsule 20, which in Fig. 5 corresponds to only a weak contrast between the mentioned areas of the capsules 20.

[0035] The first measuring device 30 and the second measuring device 32 each communicate with a respective associated evaluation unit 38, 40. Alternatively, the pharmaceutical production plant 10 comprises only one common evaluation unit 38 or 40, which communicates with both the first measuring device 30 and the second measuring device 32.

[0036] The at least one evaluation unit 38, 40 is designed to automatically evaluate the temperatures and / or temperature changes detected by the measuring device 30, 32.

[0037] The first measuring device 30 detects temperatures and / or temperature changes and, through spatial allocation of the temperatures, also the positioning, extent and / or completeness of a seal of a freshly produced sealing area 24 of a capsule 20.

[0038] The second measuring device 32 detects temperatures and / or temperature changes and, through spatial allocation of the temperatures, also the positioning, extent and / or completeness of a seal of an at least partially dried sealing area 24 of a capsule 20.

[0039] In an alternative embodiment, not shown in the drawing, no drying section 18 is provided. In this case, capsules 20 remain in the sealing device 16 for the duration of the drying process after application of a sealing liquid 22. A measuring device 30 associated with the sealing device 16 preferably records the temperature states of both freshly produced sealing areas 24 and partially or fully dried sealing areas 24.

[0040] The evaluation units 38, 40 communicate with the control unit 26. For example, the first and second evaluation units 38, 40 can be electrically connected to the control unit 26 or communicate with each other contactlessly. If one or both evaluation units 38, 40 detect a deviation of the actual values ​​from predetermined target values ​​for the position and / or completeness and / or drying of the sealing areas 24, the process parameters for operating the sealing device 16—for example, a duration and / or a quantity and / or a position of an application of the sealing liquid 22—are automatically adjusted by the control unit 26.

[0041] The production plant 10 is suitable for use with capsules 20 having different sealing types. This will be explained below with reference to the Figuren 3 and 4 explained.

[0042] A capsule 20 has a capsule shell 42. The capsule shell 42 is formed from a first shell part 44 and a second shell part 46. Each shell part 44 and 46 has a wall 50 extending rotationally symmetrically about a common extension axis 48, which wall delimits a receiving space 52 that serves to receive pharmaceutical active ingredients. A free end 54 of each shell part 44, 46 is closed, and a second end 56 has an opening 58, 60 facing the inner receiving space 52. The diameter of the opening 58 of a first shell part 44 is larger than a diameter of the opening 60 of the second shell part 46, such that the second shell part 46 can be inserted with its opening 60 into the opening 58 of the first shell part 44 to form the capsule shell 42.

[0043] Fig. 2 shows an embodiment of a capsule 20 with a concealed seal 36. Before the first shell part 44 and the second shell part 46 are plugged together, sealing liquid 22 is applied in an area which is bounded radially outwardly by the second end 56 of the first shell part 44 and radially inwardly by the second end 56 of the second shell part 46.

[0044] Fig. 3 shows an embodiment of a capsule 20 with an outwardly exposed seal 36. The first and second shell parts 44, 46 are - as in the embodiment according to Fig. 2 - plugged together. A sealing area 24 is arranged radially outward relative to the walls 50 and is exposed to the surroundings of the capsule 20. Such a sealing area 24 is also referred to as banding.

Claims

1. Pharmaceutical production facility (10) comprising a measuring device (30, 32) for monitoring sealing of capsules (20), the capsules (20) having a capsule shell (42) which is formed by a first shell part (44) and a second shell part (46), the shell parts (44, 46) being provided with a sealing liquid (22) in a sealing region (24), characterized in that the measuring device (10) comprises an infrared camera (34) or a camera having an infrared filter, the measuring device (30, 32) detecting a temperature or a temperature change of the sealing region (24) and / or of capsule portions adjacent to the sealing region (24).

2. Pharmaceutical production facility (10) according to the preceding claim, characterized in that the pharmaceutical production facility (10) comprises an evaluation unit (38, 40), the evaluation unit (38, 40) being designed to automatically evaluate the temperatures and / or temperature changes detected by the measuring device (30, 32).

3. Pharmaceutical production facility (10) according to either of the preceding claims, characterized in that the pharmaceutical production facility (10) comprises a sealing device (16) for sealing the capsules (20) and a control unit (26) which specifies method parameters for the duration and / or quantity and / or position of the application of the sealing liquid (22) to a capsule (20).

4. Pharmaceutical production facility (10) according to claim 3 with reference to claim 2, characterized in that the control unit (26) communicates with the evaluation unit (38, 40).

5. Pharmaceutical production facility (10) according to either claim 3 or claim 4, characterized in that the measuring device (30) is arranged above the sealing device (16) with respect to the direction of gravity (28).

6. Pharmaceutical production facility (10) according to any of the preceding claims, characterized in that the pharmaceutical production facility (10) comprises a drying line (18) along which the capsules (20) are transported during drying of the sealing liquid (22).

7. Pharmaceutical production facility (10) according to any of the preceding claims, characterized in that a plurality of measuring devices (30, 32) arranged spatially offset from one another is provided, the measuring devices (30, 32) each having an infrared camera (34) or a camera having an infrared filter.

8. Method for monitoring a seal of capsules (20), wherein the capsules (20) have a capsule shell (42) which is formed by a first shell part (44) and a second shell part (46), wherein the shell parts (44, 46) will be provided or are provided with a seal-tight sealing liquid (22) in a sealing region (24), in particular using a pharmaceutical production facility (10) according to any of the preceding claims, comprising: a) detecting a temperature or a temperature change of the sealing region (24) and / or of capsule portions adjacent to the sealing region (24), and b) evaluating the temperature or temperature change.

9. Method according to claim 8, characterized in that a detection according to a) takes place during the application of sealing liquid (22) in the sealing region (24) and / or after the application of sealing liquid (22) in the sealing region (24).

10. Method according to either claim 8 or claim 9, characterized in that method parameters for the duration and / or quantity and / or position of the application of the sealing liquid (22) to a capsule (20) are adapted depending on the temperature or temperature change detected according to a).