EP3011280A1 - Dispositif et procédé pour déterminer le poids de produits en particulier pharmaceutiques au moyen d'une source de rayons x - Google Patents

Dispositif et procédé pour déterminer le poids de produits en particulier pharmaceutiques au moyen d'une source de rayons x

Info

Publication number
EP3011280A1
EP3011280A1 EP14726571.4A EP14726571A EP3011280A1 EP 3011280 A1 EP3011280 A1 EP 3011280A1 EP 14726571 A EP14726571 A EP 14726571A EP 3011280 A1 EP3011280 A1 EP 3011280A1
Authority
EP
European Patent Office
Prior art keywords
container
weight
product
evaluation region
evaluation
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Withdrawn
Application number
EP14726571.4A
Other languages
German (de)
English (en)
Inventor
Iulian Maga
Martin Vogt
Jens Schlipf
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Robert Bosch GmbH
Original Assignee
Robert Bosch GmbH
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Robert Bosch GmbH filed Critical Robert Bosch GmbH
Publication of EP3011280A1 publication Critical patent/EP3011280A1/fr
Withdrawn legal-status Critical Current

Links

Classifications

    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01G—WEIGHING
    • G01G9/00—Methods of, or apparatus for, the determination of weight, not provided for in groups G01G1/00 - G01G7/00
    • G01G9/005—Methods of, or apparatus for, the determination of weight, not provided for in groups G01G1/00 - G01G7/00 using radiations, e.g. radioactive
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J3/00—Devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms
    • A61J3/07—Devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms into the form of capsules or similar small containers for oral use
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
    • B65B—MACHINES, APPARATUS OR DEVICES FOR, OR METHODS OF, PACKAGING ARTICLES OR MATERIALS; UNPACKING
    • B65B3/00—Packaging plastic material, semiliquids, liquids or mixed solids and liquids, in individual containers or receptacles, e.g. bags, sacks, boxes, cartons, cans, or jars
    • B65B3/26—Methods or devices for controlling the quantity of the material fed or filled
    • B65B3/28—Methods or devices for controlling the quantity of the material fed or filled by weighing
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01G—WEIGHING
    • G01G17/00—Apparatus for or methods of weighing material of special form or property

Definitions

  • the invention relates to a device and a method for
  • WO 2012/013368 AI known.
  • An X-ray source generates a cone of radiation which transmits at least one pharmaceutical product.
  • a sensor element detects the radiation of the irradiated pharmaceutical product and supplies it to an evaluation device.
  • a reference object is arranged in the beam path of the radiation cone, the radiation of the transilluminating reference object being detected by the sensor element and supplied to the evaluation unit, wherein the pharmaceutical product and the reference object are positioned in the radiation cone with respect to the radiation cone in non-overlapping arrangement.
  • the invention provides that the image of the irradiated container is subdivided into at least one evaluation region in which the product is located, wherein an evaluation device is provided, which determines a measure of the weight of the product in the container using the evaluation region.
  • This information is directly proportional to the net weight of the filling. This determines the net weight of the product, which is of primary interest, and not just the gross weight of the container and product as in the prior art. This is particularly advantageous in the case of small filling quantities, since in these cases the weight of the container has a great influence on the accuracy of the weight determination.
  • Evaluation device located within the evaluation region gray values and / or pixels of the sensor evaluates to determine the weight. By a targeted evaluation of the areas of interest, the accuracy of weight determination can be further increased. The net weighting falsifying sizes can easily be counted out.
  • Evaluation device for determining the weight of the product uses a measure of an area of the evaluation region, in particular those pixels of the sensor that are within the evaluation region.
  • the information of the planar sensor for weight determination can be used without additional sensors or measurements would be necessary. This simplifies the structure of the device.
  • the evaluation device determines the evaluation region via the respective gray values of the image, in particular if the gray values fall below or exceed a certain threshold or if, in particular, adjacent gray values deviate from one another by a certain amount. This allows the evaluation region to be set automatically.
  • X-ray source for teaching through with product filled container radiates through and that the evaluation device creates a reference line when learning, the different gray levels in the evaluation region
  • a weighing device which detects a measure of the weight of the product and the
  • At least one reference object is provided, which in the radiation passage of
  • X-ray source is arranged, and having different thicknesses. Especially by using a reference object with
  • the gray values can be reliably in a
  • a receiving means is provided for receiving at least one container, with a
  • Subsidies which are the means of registration of the X-ray source moves to produce the image.
  • This arrangement is particularly suitable for containers that are fed at high speed to different workstations. As a result, high application rates can be achieved.
  • Fig. 1 shows the basic principle of image formation, which on
  • Fig. 2 images of a filled container and a filled
  • FIG. 6 shows a further modified device for determining weight
  • FIG. 7 shows an image of several irradiated containers and of the
  • X-ray source 28 which irradiates the containers 3. Behind it is a sensor 30 with a sensor surface 32, the
  • the X-ray source 28 faces.
  • the sensor 30 is used to create an X-ray image or image 12, 13 of the irradiated container 3.
  • the sensor surface 32 preferably comprises a plurality of
  • each one Output signal which is referred to below as the gray value.
  • the gray value For this purpose, for example, over the pixels of the CMOS sensor is a
  • the Scintillation layer applied, which converts the X-ray energy into visible light.
  • the pixel of the sensor 30 generates, depending on the amount of light, a charge (analog), which is preferably converted into a digital signal G.Grauwerf '), which is used for weight determination.
  • the image 12 is generated via the output signals of the areally arranged sensor elements. In principle, other radiation detection means can be used as sensors.
  • the reference element 35 is located in non-overlapping arrangement next to the containers 3 and is also irradiated. The resulting image, the sensor 30 also takes on.
  • FIG. 2 shows an image 12 that the sensor 30 receives from a container 3 filled with product 2 and filled with radiation.
  • the evaluation region 11 is selected such that only those areas of the container 3 which are filled with product 2 are present therein.
  • the determination of the filled area could, for example, by means of a gray value detection or
  • Threshold detection done. The boundary of the evaluation region 11 is placed on those areas where adjacent gray values become significant
  • the evaluation region 11 could also be selected manually.
  • FIG. 3 shows the essential method steps 101 to 103 in the form of a flow chart.
  • a first step 101 the system is taught in on the product 2 used.
  • a second step 102 the image 12 of the container 3 to be tested filled with product 2 is produced.
  • the evaluation region 11 of the image 2 is evaluated to determine the net weight of the product 2 contained in the container 3. Steps 101 to 103 will be explained in more detail later.
  • FIG. 4 shows the device 10 which is suitable for carrying out the described method. This is exemplified by the concrete example a capsule filling machine, for which the invention is particularly suitable, but not limited thereto.
  • a machine for filling and closing of a capsule lower part and an attached cap container 3 has a twelve-part, gradually rotated about a vertical axis feed wheel 40, at its stations 1 to 12 on the circulation path, the individual
  • Treatment facilities are arranged. Other divisions of the feed wheel 40 such as a 15-piece would be conceivable. At stations
  • the empty containers to be filled 3 are abandoned and aligned disorderly.
  • the containers 3 are then ordered into a capsule holder 42 of a feed wheel 20.
  • the still closed containers 3 are opened.
  • the container 3 is filled with the product 2.
  • the filled container 3 is closed.
  • the containers 3 by a
  • the weighing device 44 can make different measurements. On the one hand, the weighing device 44 for
  • Initialization make a weighing of the empty or filled container 3.
  • the weighing device 44 could also be used for comparison weighing during running production for checking the described X-ray based measuring system.
  • a closing pressure check of the closed container 3 is carried out.
  • defective containers 3 in station 10 are ejected properly only in station 11.
  • the containers 3 pass from the capsule holder 42 upwards into the radiation passage 36 of an X-ray source 28.
  • faulty containers 3 can still be discarded with the aid of a switch.
  • an ampoule is provided as a container 3, which is provided with a liquid product 2, in particular a
  • FIG. 6 shows a further modified device 10 for determining weight.
  • the device 10 has a feed wheel 51, which is rotated stepwise in a vertically arranged axis of rotation 52.
  • shots 54 for the interchangeable attachment of format parts 55 are formed at uniform angular intervals.
  • the format parts 55 are each a plurality of, in particular also vertically aligned, acting as receptacles for the containers 3 receiving bores 56 are formed, each having a height or length, which makes it possible to receive a plurality of receptacles 3 stacked as a series standing in the mounting holes 56 ,
  • the format parts 55 each have a reference object 35, which in addition to the receiving bores 56 also in the radiation passage 36 of the
  • the format parts 55 are made of a material, in particular of plastic, which is permeable to the X-ray radiation.
  • the receiving bores 56 of the format parts 55 are filled by means of shaft-shaped feed troughs 57 from a mass storage, not shown, with the containers 3, wherein in the region of the feed troughs 57
  • each locking means 20 are arranged.
  • a plurality of X-ray sources 28 are arranged on the conveying path of the feed wheel 51 outside its outer periphery.
  • the number of X-ray sources 28 preferably corresponds to the number of feed channels 57, so that the feed wheel 51
  • Reference object 35 visible, which has different levels of gray 38.
  • the reference object 35 is constructed in a staircase shape with different thicknesses. At the respective different thicknesses arise different
  • Grayscale 38 as explained in more detail below.
  • the evaluation region 11 and the contour 24 of the container 3 are already defined or determined.
  • the reference object 35 is made of a material having similar atomic properties as the pharmaceutical product 2 to be irradiated, i.
  • the reference object 35 has different thicknesses when viewed over the cross section.
  • the reference object 35 may be wedge-shaped.
  • the reference object 35 has a series of steps that cause a discrete change in the thickness of the reference object 35.
  • the attenuation (gray value) of the reference object 35 is greater at one point and smaller at a different location than the attenuation by the pharmaceutical product 2. Due to the mentioned geometric design of the reference object 35, these have different thicknesses that at irradiation by means of the X-ray source 28 on the sensor element 30 to produce different levels of gray 38. Individual stages of the reference object 35 have different gray values 38.
  • the weight determination of the product 2 contained in a container 3 takes place in principle as follows: In a not shown, taking place in advance
  • Reference object 35 so that a certain gray value 38 of the reference object 35 are assigned a certain thickness.
  • This pixel represents a certain area, for example a square with an edge length of ⁇ . Then, for each pixel of the container 3, the detected gray value of the pixel is assigned to an (identical) gray value 38 on the reference object 35. This gray value can (due to the assignment of the thicknesses to the gray values 38 am
  • Reference object 35 are assigned a certain thickness. After this is done pixel by pixel, an average thickness is determined from individual thicknesses. This average thickness is now calculated with the total number of
  • Pixels and their known area multiplied, so that a virtual volume of the product 2 can be determined.
  • weight of the product 2 located in the container 3 can be assigned to the virtual volume.
  • an image of the relevant reference object 35 is also included at the same time. This allows changes to the grayscale on
  • the evaluation device 14 can assign this detected gray value with a correction factor and / or offset which adapts the current gray value to the original gray value and thus equalizes the interference influences . Based on this general approach is done below
  • a modified form may be a partial evaluation of a defined area of the container 3 be.
  • the defined area is defined as the evaluation region 11 in such a way that the product 2 is safely located in this part of the container 3. This determination could also be made manually, in particular if the product 2 does not cause any significant, sudden gray value changes.
  • the device 10 operates as follows.
  • the system is trained on the filled product 2.
  • the x-ray source 28 is irradiated through the filled container 3 together with the reference object 35.
  • the sensor 30, which has two-dimensionally arranged pixels, detects the radiation striking it, which was damped by the container 3 and the reference object 35. This results in an image 12, the different gray values give conclusions on the container 3 and the product contained therein 2.
  • Figure 2 rises in the lower part of the
  • the evaluation unit 14 now sets the image using an image processing algorithm, for example using a threshold detection
  • Evaluation region 11 fixed.
  • the boundaries of the evaluation region 11 are determined if the gray values of adjacent pixels or pixel areas differ significantly by a certain threshold or if gray values reach a certain absolute threshold.
  • the evaluation region 11 selected according to this alternative could be set once and maintained for the subsequent weight acquisition steps.
  • the evaluation unit 14 creates a reference line of the container 2 filled with product 2 in the evaluation region 11.
  • the damping curve ultimately establishes the relationship between the signals detected by the sensor 30 Information such as the respective gray values of the image 12 or the pixels and the associated net weight of the product 2.
  • the gray values are compared with a known reference object 35 for weight determination.
  • only those pixels are evaluated that are within the evaluation region 11.
  • the respective gray value is compared with the gray value 38 of the reference object 35, whose associated thickness is known. This assigns a thickness to the respective pixel. This takes place for all pixels located within the evaluation region 11, resulting in an average thickness for the known area of the evaluation region 11. For example, the number of lying within the evaluation region 11 pixels whose size is known, is a measure of the area. This virtual volume of
  • Evaluation region 11 can be assigned a weight. This could be a
  • Weighing device 44 detect the weight of the filled container 3.
  • the net weight could be determined from the gross weight of the filled container 3 less the tare weight of the empty container 3. This would be possible in the arrangement according to FIG.
  • the container 3 could be emptied and only the product 3 weighed, for example by means of a separate laboratory balance. This manual variant could be at the
  • the relationship between the virtual volume of the evaluation region 11 and the net weight of the product 2 is established via a linear curve. This relationship could be conveniently made manually (e.g., manually entering the net weights determined manually on a laboratory balance while retaining the assignment).
  • the evaluation unit 14 accesses this reference line again.
  • the first step 101 could be performed with several, different containers 3 and the results suitably averaged or interpolated be used to create the reference line.
  • the learning process is then
  • the image 12 of the container 3 to be tested is generated as shown in FIG.
  • the evaluation region 11 is determined as already described in step 101.
  • the evaluation unit 14 determines the net weight of the product 2. Only those pixels which lie within the evaluation region 11 are evaluated.
  • the respective gray value is compared with the gray value 38 of the reference object 35, whose associated thickness is known. This assigns a thickness to the respective pixel. This takes place for all pixels located within the evaluation region 11, resulting in an average thickness for the known area of the evaluation region 11.
  • the number of lying within the evaluation region 11 pixels whose size is known is a measure of the area.
  • This virtual volume of the evaluation region 11 can be assigned to the net weight of the product 2 located in the container 3 via the reference line determined in step 101.
  • Evaluation region 11 only in the filled area affects the allowable possible tolerance of the tare weight of the empty container 3 only to a small extent.
  • production fluctuations of the tare weight of empty containers 3 may be greater than the maximum permissible
  • the procedure described is particularly suitable for hard gelatin capsules, but also for glass containers such as vials, ampoules, or the like, but is not limited thereto.

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  • Health & Medical Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Toxicology (AREA)
  • Physics & Mathematics (AREA)
  • General Physics & Mathematics (AREA)
  • Analysing Materials By The Use Of Radiation (AREA)

Abstract

Dispositif et procédé permettant de déterminer le poids d'un produit (12) en particulier pharmaceutique qui se trouve dans un contenant (3). Ledit dispositif comprend au moins une source de rayons X (28) qui génère un chemin de rayonnement (18) permettant de radiographier le contenant (3). Un capteur (14) représente le rayonnement du contenant (3) radiographié sous la forme d'une image (12). Un dispositif d'évaluation (14) divise l'image (12) du contenant (3) radiographié en au moins une zone d'évaluation (11) dans laquelle se trouve le produit (2), le dispositif d'évaluation (14) déterminant, à l'aide de la zone d'évaluation (11), le poids net du produit (2) se trouvant dans le contenant (3) radiographié.
EP14726571.4A 2013-06-19 2014-05-22 Dispositif et procédé pour déterminer le poids de produits en particulier pharmaceutiques au moyen d'une source de rayons x Withdrawn EP3011280A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
DE102013211501.6A DE102013211501A1 (de) 2013-06-19 2013-06-19 Vorrichtung und Verfahren zur Gewichtsbestimmung von insbesondere pharmazeutischen Produkten mittels einer Röntgenstrahlungsquelle
PCT/EP2014/060529 WO2014202327A1 (fr) 2013-06-19 2014-05-22 Dispositif et procédé pour déterminer le poids de produits en particulier pharmaceutiques au moyen d'une source de rayons x

Publications (1)

Publication Number Publication Date
EP3011280A1 true EP3011280A1 (fr) 2016-04-27

Family

ID=50828890

Family Applications (1)

Application Number Title Priority Date Filing Date
EP14726571.4A Withdrawn EP3011280A1 (fr) 2013-06-19 2014-05-22 Dispositif et procédé pour déterminer le poids de produits en particulier pharmaceutiques au moyen d'une source de rayons x

Country Status (3)

Country Link
EP (1) EP3011280A1 (fr)
DE (1) DE102013211501A1 (fr)
WO (1) WO2014202327A1 (fr)

Families Citing this family (1)

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Publication number Priority date Publication date Assignee Title
DK3078944T3 (da) * 2015-04-07 2020-05-04 Mettler Toledo Llc Fremgangsmåde til bestemmelse af objekters masse ud fra en flerhed af røntgenbilleder taget ved forskellige energiniveauer

Family Cites Families (4)

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Publication number Priority date Publication date Assignee Title
JP3468498B2 (ja) * 1997-02-25 2003-11-17 株式会社日立エンジニアリングサービス 配管等内堆積状態評価方法
DE102005016124A1 (de) * 2005-04-08 2006-10-12 Robert Bosch Gmbh Sensorvorrichtung einer Verpackungsmaschine
EP2194374B1 (fr) * 2007-09-26 2016-01-13 Ishida Co., Ltd. Appareil d'examen
CN103025300B (zh) 2010-07-28 2015-08-19 罗伯特·博世有限公司 用于借助伦琴辐射源确定制药产品的重量的设备和方法

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
See references of WO2014202327A1 *

Also Published As

Publication number Publication date
WO2014202327A1 (fr) 2014-12-24
DE102013211501A1 (de) 2014-12-24

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