DEVICE AND METHOD FOR DETERMINING AT LEAST ONE PHYSICAL PARAMETER OF PHARMACEUTICAL PRODUCTS
20200064255 ยท 2020-02-27
Inventors
Cpc classification
G01N33/15
PHYSICS
G01N21/13
PHYSICS
International classification
G01N21/13
PHYSICS
G01N33/15
PHYSICS
Abstract
The invention relates to a device for determining at least one physical parameter of pharmaceutical products such as, for example, tablets (T), pills, oblongs or similar, the device having at least one examining station (1). The device has, in addition, at least one automatic system for transporting the products to and/or between and/or inside and/or from the or each examining station (1). The transport system has at least one robotic arm (2) having at least one controllable holding mechanism (3) for the pharmaceutical products. The travel paths and the spatial orientation of the holding mechanism (3) can be freely programmed.
Claims
1. A device for determining at least one physical and/or chemical parameter of pharmaceutical products (T), such as tablets, pills, oblongs or similar, with at least one examining station (1) as well as with at least one automatic transport system for the products to and/or between and/or within and/or from one or more examining stations, wherein the transport system comprises a controllable holding mechanism (3) for a friction-fitting and/or a form-fitting holding of the pharmaceutical products (T), wherein the travel paths and spatial orientation of the holding mechanism (3) are freely programmable.
2. The device according to claim 1, wherein the controllable holding mechanism (3) is arranged on a freely programmable robotic arm (2).
3. The device according to claim 1, wherein at least one examining station (1) is a device for scanning or reflection measurement which comprises a support surface (5) for the pharmaceutical product (T).
4. The device according to claim 3, wherein the device for scanning measurement has a support (6) which is impervious to wavelengths used and, at least during the scanning measurement, the support holds the product at least partially in a form-fitting manner, the support comprising an aperture that can be fully covered by the product (T).
5. The device according to claim 4, wherein the support (6) is made of an elastically flexible material.
6. The device according to claim 1, wherein the holding mechanism (3) comprises at least two gripper jaws (8) that can be adjusted relative to each other.
7. The device according to claim 6, wherein the gripper surface of the respective opposite gripper jaws (8) is shaped in such that an at least two-point support is formed between the gripper jaws (8).
8. The device according to claim 6, wherein the gripper surfaces of the gripper jaws (8) are shaped to complement at least one part of a peripheral contour of the products (T).
9. The device according to claim 6, wherein the gripper jaws (8) are: opposite each other in a pincer-like manner, closable when moving toward each other, and openable when moving away from each other.
10. The device according to claim 6, wherein the gripper jaws are: arranged along a closed contour, and have a central free space for accommodating the pharmaceutical product (T).
11. The device according to claim 6, wherein the controllable holding mechanism (3) and/or any gripper jaws (8) comprise sensors for determining the path of any gripper jaws (8) and/or the force exerted on the pharmaceutical products (T).
12. The device according to claim 1, wherein at a transfer position of the pharmaceutical product (T) to the transport system, a turntable is arranged on which the product (T) comes to lie immediately before being picked up in a friction-fitting or form-fitting manner by the transport system.
13. The device according to claim 6, wherein a gripper surface of at least one of the gripper jaws (8) is covered with an elastic layer (9) and/or a layer (9) which is impervious to wavelengths used in scanning measurements.
14. The device according to claim 6, wherein the gripper jaws (8) have protrusions projecting inwards beyond a clamped product (T) and wherein a height of the gripper jaws (8) projecting beyond the protrusion is smaller than a thickness of the products (T).
15. The device according to claim 4, wherein the transport system (2) is configured to exert a pressing force on the product (T) in a direction of the support (6).
16. A method of determining at least one physical parameter of pharmaceutical products (T), such as tablets, pills, oblongs and similar, wherein at least one chemical or physical property is examined and the product is transported and manipulated between and/or during and/or after at least one test procedure by an automatic transport system (2) wherein a transport path of the product (T) and its spatial orientation are pre-programmed at least partially independently of a spatial technical set-up and is travelled by means of a robotic arm (2).
17. The method according to claim 16, wherein at least one property of the product (T) is determined by means of a scanning and reflection measurement.
18. The method according to claim 17, wherein at least for the scanning or reflection measurement, the product (T) is fixed in place in relation to the device for scanning measurement, preferably with a pressing force being exerted in the direction of a support (6).
19. The method according to claim 17, wherein during the scanning or reflection measurement the product is left moveable, or wherein several measurements are carried out, preferably at different points of the products (T).
20. The method according to claim 16, wherein during at least part of the transport path, the product (T) is coupled to a holding mechanism (3) of the transport system in a friction-fitting and/or form-fitting manner.
21. The method according to claim 16, wherein after completion of all tests, the product (T) is deposited by the transport system (2) in a repository (10) or is transferred to other examining systems, repositories, or manipulation systems.
Description
BRIEF DESCRIPTION OF THE DRAWINGS
[0038] The list of reference numbers, as well as the technical content of the patent claims and figures, forms part of the disclosure. The figures are described in an interrelated and overall manner. The same reference numbers denote identical components, reference numbers with different indices denote functionally-identically or similar components.
[0039] In these:
[0040]
[0041]
[0042]
[0043]
[0044]
[0045]
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DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS
[0047]
[0048] In accordance with the invention the transport system comprises at least one robotic arm 2 with at least one controllable holding mechanism 3 for the pharmaceutical products. Preferably the travel paths and the spatial orientation of the holding mechanism 3 on this robotic arm 2 are freely programmable. In this way the pharmaceutical product can also be moved to any position within the reach or the robotic arm 2, and, with appropriate movable attachment of the holding mechanism 3 on the free end of the robotic arm 2, also into any spatial orientation. More particularly, the robotic arm 2 can be controlled in such a way that the transport path of the product and its spatial orientation are pre-programmed at least partially independently of the spatial technical set-up and travelled by way of the robotic arm 2.
[0049] At least one of the examining stations 1 is a device for scanning or reflection measurement. Thus, for determining the active substance in a pharmaceutical product, measurements with NIR (Near Infra-Red), RAMAN and similar detectors are usual. In particular, for carrying out such scanning or reflection measurements as part of a test cycle for pharmaceutical products, this product, for example the tablet T shown in
[0050] For all manipulating procedures the manner of gripping and clamping the products described below is advantageous. However, this applies in particular to the manipulation procedures in relation to the scanning and reflection measurement.
[0051] Preferably the tablet T is clamped in a form-fitting manner and thus securely held by means of two gripper jaws 8 of the holding mechanism 3 at the free of the robotic arm 2 that can be adjusted relative to each other. In accordance with an advantageous form of embodiment the gripper jaws 8 can also be sprung in order to compensate for the dimensional tolerances of the products or to react to changes in size during temperature changes of the products (change from warm to cold during tablet production). Due to this secure clamping, the pharmaceutical product can not only be placed down by the holding mechanism 3 of the robotic arm 2, but pressed onto the plastic disc 6 with an adjustable force so that form-fitting comes about between the lower side of the table T and the upper side of the plastic disk 6 which prevents any gaps for undesirable scattered light or scattered radiation in the direction of the radiation detector. For this, the transport system, in particular the robotic arm 2, is of course configured to exert a pressing force acting on the product in the direction of the support. In this way, at least for the scanning or reflection measurement the product T is fixed in place in relation to the device 1. This fixing is preferably achieved or supported in that a pressing force is exerted on the product in the direction of the support. In all events, according to the present invention, during at least part of the transport path the product is coupled with the transport system, preferably a holding mechanism 3 of the transport system configured as a robotic arm 2, in a friction-fitting and/or form-fitting manner.
[0052] However, fixing of the pharmaceutical product for the scanning or reflection measurement is not mandatory. Rather, it can be advantageous for certain measurements if the product is left movable during the scanning or reflection measurement. For example, through opening the gripper jaws 8 after placing down the product, a tablet T clamped in gripper jaws 8 is released for a short time and only for the scanning or reflection measurement. After completion of these examination procedures the product T is preferably coupled to the transport system again in the same way as described above through gripping with holding mechanism 3 thereof. Particularly on the movably left product T, but if need be also on products left coupled to the transport system, several measurements can advantageously be carried out, preferably at different points of the product T. Especially in the case of elongated or large-area products such as oblongs, measurements can be carried out at different points of the product and a mean value for the measurement over the entire product can be determined.
[0053] In order to improve the holding effects of the holding mechanism 3 on the robotic arm 2 on the pharmaceutical products even further, to make them more flexible and partially also to prevent the scattered radiation even more reliably, the following gripper jaw 8 variants in particular are possible in the context of the invention.
[0054] Thus the gripper surface facing the respective opposite gripper jaws 8 could be shaped so that for the product an at least two-point support for the product is formed. On the other hand the gripper surfaces of the gripper jaws 8 could also be shaped to complement at least part of the peripheral contour of the products. For very gentle clamping of the products in the gripper jaws 8 a form of embodiment can be advantageous in which the gripper surface of at least one of the gripper jaws 8 is covered with an elastic layer 9, preferably of a plastic material. This layer 9 can also constitute an additional seal to prevent undesirable scattered radiation during the scanning measurement.
[0055] In any event the holding mechanism 3 is designed in such a way that at least one of the gripper jaws 8 has at least one recess which is shaped so that for accommodating the pharmaceutical product between the contact surfaces there is an intermediate space, which can be enlarged to open the gripper jaw 8 device and made smaller to close it. The gripper jaws 8 arepossibly adapted or adaptable to the productshaped in such a way that with the gripper jaws 8 open, the product to be tested can be introduced into the intermediate space via an access opening, and held in the intermediate space between the gripper jaws 8 in a form-fitting and/or friction-fitting manner when the gripper jaw 8 arrangement is closed. To do this the procedure is preferably as follows: the gripper jaws 8 of the holding mechanism 3 are opened, the product is then placed on a support surface, the holding mechanism 3 is preferably moved in such a way that the object comes to lie in the intermediate space. Finally the gripper jaws 8 are closed and through this the product is positioned and possibly orientated at a point determined by the shape of the contact surfaces. Preferably all the steps are carried out automatically, e.g. controlled by computer.
[0056] Furthermore, especially for exerting a pressing force directed towards the tablet nest 4 on the tablet T or every other pharmaceutical product on the gripper jaws 8, inwardly projecting protrusions, projecting beyond a clamped product T can be provided, which thereby slightly constrict the free opening above the product. The height of the gripper jaws 8 projecting beyond the base of the protrusion is preferably smaller than the thickness of the products.
[0057] The variant of the invention hitherto mentioned as an example used opposing pincer-shaped gripper jaws 8 which are closable on moving toward each other and openable when moving away from each other. These are preferably arranged in parallel to each other and are essentially movable transversely to their longitudinal extent, preferably held by a base unit of the holding mechanism 3 and by means of this holding mechanism 3 connected, for example, to the robotic arm 2. Particularly preferably the gripper jaws 8 are attached in the holding mechanism 3 in an interchangeable manner in order to adapt them to different types of pharmaceutical products T or for repair or replacement in the event of faults.
[0058] Alternatively, in addition to pincer grippers, which can, if need be, be supplemented with ejectors for any products T sticking to the gripper jaws 8, forms of embodiment are also possible in which the gripper jaws 8 are arranged along a closed contour. In
[0059] In the case of all gripper variants and forms of embodiment of gripper jaws 8 and transport system the controllable holding mechanism and/or at least one of the gripper jaws 8 can comprises sensors to determine the path of any gripper jaws 8 and/or the force exerted on the pharmaceutical products T. By way of a path sensor the working path travelled by the holding structure, for example at least one gripping jaw 8, during the holding of the product T, can be determined. In the control system of the holding mechanism 3 or of the entire transport system this current path is compared with a reference value which has previously been determined for a correct gripping procedure with a correct orientation of the pharmaceutical product T. Thus, not attaining the reference value can indicate an incorrect orientation of the product T, while exceeding it can be a sign of unintentional destruction of the product during the gripping procedure or also that there is no product present to transfer to the transport system 2, 3.
[0060] Similarly, via determination of the force required to grip the product and comparing this value with a reference value, conclusions about the presence and correct orientation of the product can be drawn. For forces greater than the reference value either incorrect gripper function with increased friction or jamming of the gripper jaws 8 can be concluded, or this indicates incorrect orientation of the project T. Force measurements below the reference value on the other hand can occur due the product not being present or an incorrect product (with less strength than expected).
[0061] Both procedures, alone or in combination, could of course subsequently prevent incorrect measurements due to incorrect positioning or the products or due to an incorrect product.
[0062] Should incorrect orientation of the product T be determined, a further embodiment of the device according to the invention with a turntable at the transfer position of the pharmaceutical product to the transport system can be used. On such a turntable, if incorrect orientation is detected, immediately before friction-fitting and/or form-fitting picking up by the transport system, the product T can be turned into the correct position for being taken over by the transport system.
[0063] Due to the free programmability of the robotic arm 2 and the fact that there are no predetermined paths for the pharmaceutical products due to transport system restrictions or path specifications, the examining stations of the device according to the invention can be travelled to in any sequence. After scanning and reflection measurement, this makes it possible to return the pharmaceutical product to an examination station 1 or a complete tablet testing device, in order, for example to measure the hardness or another physical parameter.
[0064] On the other hand, after the scanning or reflection measurement the tablets T or other products can also be placed directly into a tube 10 or other repository with freely programmable placement positions, as in
LIST OF REFERENCE NUMBERS
[0065] 1 Examining station [0066] 2 Robotic arm [0067] 3 Holding mechanism [0068] 4 Tablet nest [0069] 5 Lower part [0070] 5a Carrying structure [0071] 6 Plastic disk [0072] 7 Radiation guide [0073] 8 Gripper jaw [0074] 9 Elastic layer [0075] 10 Tablet tube [0076] T Tablet