Classifications

• • G—PHYSICS
  • G01—MEASURING; TESTING
  • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
  • G01N23/00—Investigating or analysing materials by the use of wave or particle radiation, e.g. X-rays or neutrons, not covered by groups G01N3/00 – G01N17/00, G01N21/00 or G01N22/00
  • G01N23/02—Investigating or analysing materials by the use of wave or particle radiation, e.g. X-rays or neutrons, not covered by groups G01N3/00 – G01N17/00, G01N21/00 or G01N22/00 by transmitting the radiation through the material
  • G01N23/04—Investigating or analysing materials by the use of wave or particle radiation, e.g. X-rays or neutrons, not covered by groups G01N3/00 – G01N17/00, G01N21/00 or G01N22/00 by transmitting the radiation through the material and forming images of the material
  • G01N23/043—Investigating or analysing materials by the use of wave or particle radiation, e.g. X-rays or neutrons, not covered by groups G01N3/00 – G01N17/00, G01N21/00 or G01N22/00 by transmitting the radiation through the material and forming images of the material using fluoroscopic examination, with visual observation or video transmission of fluoroscopic images
• • 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
  • A61J3/071—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 into the form of telescopically engaged two-piece capsules
  • A61J3/074—Filling capsules; Related operations
• • G—PHYSICS
  • G01—MEASURING; TESTING
  • G01G—WEIGHING
  • G01G17/00—Apparatus for or methods of weighing material of special form or property
• • 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
• • G—PHYSICS
  • G21—NUCLEAR PHYSICS; NUCLEAR ENGINEERING
  • G21K—TECHNIQUES FOR HANDLING PARTICLES OR IONISING RADIATION NOT OTHERWISE PROVIDED FOR; IRRADIATION DEVICES; GAMMA RAY OR X-RAY MICROSCOPES
  • G21K5/00—Irradiation devices
  • G21K5/10—Irradiation devices with provision for relative movement of beam source and object to be irradiated
• • G—PHYSICS
  • G01—MEASURING; TESTING
  • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
  • G01N2223/00—Investigating materials by wave or particle radiation
  • G01N2223/60—Specific applications or type of materials
  • G01N2223/633—Specific applications or type of materials thickness, density, surface weight (unit area)
• • G—PHYSICS
  • G01—MEASURING; TESTING
  • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
  • G01N2223/00—Investigating materials by wave or particle radiation
  • G01N2223/60—Specific applications or type of materials
  • G01N2223/652—Specific applications or type of materials impurities, foreign matter, trace amounts

Definitions

• the invention relates to a control device according to the preamble of claim 1.
• a control device is from the post-published
• the weight of capsules filled with a pharmaceutical substance can be determined by irradiating the capsules with X-ray radiation by means of the known control device. Furthermore, it is possible, e.g. Foreign bodies or the like, which reach the inside of the capsule during filling, to recognize. The from the
• A1 known control device has a tubular or
• Shaft-shaped conveying element for feeding the capsules in the region of the X-ray source, wherein the capsules are conveyed in the conveying element as a vertically arranged row.
• the conveying element must be adapted very closely in terms of its cross-section to the format of the pharmaceutical products to be examined. This is also necessary in the previously known control device because the X-ray source transilluminates the pharmaceutical product in a direction perpendicular to its longitudinal axis.
• the known control device has a very high performance for each format to be processed. However, especially in a batch or format change, it is necessary to adapt the conveyor to the new format of the pharmaceutical products. This is usually done by replacing the conveyor, the preferred for this purpose as a format part is formed. The replacement and the recalibration in a format change, however, require a relatively high effort.
• the invention is therefore based on the object, a control device according to the preamble of claim 1 such that it can be used for different formats of pharmaceutical products, without the need for conversion or conversion of the feeder is required .
• This object is achieved in a control device with the features of claim 1 according to the invention in that the tubular or shaft-shaped feeding device in the region of the beam path has a cross-section which is larger than the cross-section of the pharmaceutical product, and that during the irradiation in each case only a pharmaceutical Product is arranged in the region of the beam path of the radiation source.
• the feed device has a cross-section such that it can be used essentially for all formats of the pharmaceutical products to be examined which have a smaller cross-section than the feed device.
• the means for positioning and releasing the pharmaceutical product in the region of the beam path include a blocking flap which can be pivoted or displaced in a direction perpendicular to the conveying direction of the pharmaceutical product, the length of which is preferably greater than the length of the pharmaceutical product.
• the blocking flap is permeable to the radiation of the radiation source.
• the blocking flap can be arranged directly in the beam path of the radiation source, as a result of which, on the one hand, the design effort is reduced, and on the other hand, the blocking flap can simultaneously serve as a support surface for the pharmaceutical object.
• the blocking flap in which integration of the blocking flap into the feeding device is made possible, it is therefore proposed that the blocking flap is arranged with its pivot axis in the area of the feed device, forms part of the feeding device in its release position and engages in its blocking position with its side facing away from the pivot axis abuts against an opposite wall of the feeder or on the detector.
• the delivery device be further in the conveying direction downstream of the detector Blocking means for blocking the pharmaceutical product are arranged, which cooperate with a good / bad separating device.
• the pharmaceutical products by means of a conveyor device designed as a stepwise rotated conveyor in the Area of the feeding device are supplied, wherein the feed wheel has individual receptacles for the pharmaceutical objects.
• a reference object is arranged in the region of the detector for comparison with the pharmaceutical product.
• a reference object preferably has radiation properties similar to those of the pharmaceutical product to be measured and includes, for example
• Figure shows a simplified longitudinal section through a capsule control device according to the invention.
• the capsule control device 10 shown in the figure is used to check pharmaceutical products 1.
• the pharmaceutical products 1 is in particular, but not limiting, filled with a pharmaceutical and optionally additives capsules in the form of hard gelatin capsules, tablets or the like Filling weight and / or other properties, eg the presence of foreign bodies, to be checked by the capsule control device 10.
• the capsule control device 10 has a stepwise rotatable in a horizontal axis of rotation 11 feed wheel 12, which has a receptacle 13 for each pharmaceutical product 1 on its outer circumference.
• the feed wheel 12 is equipped with the pharmaceutical products 1, for example, by means of a feed chute having a shaft-like region.
• the feeding device 15 is used for individual supply of the pharmaceutical products 1 in the region of the beam path 16 and the beam cone of a radiation source, which is designed in particular as an X-ray source 17.
• a radiation source which is designed in particular as an X-ray source 17.
• the pharmaceutical product 1 to be examined is transilluminated, the radiation penetrating the pharmaceutical product 1 being detected by means of a detector 18 arranged on the side of the pharmaceutical product 1 opposite the X-ray source 17.
• the detector 18 is designed in particular as an image-receiving detector 18 and coupled to an electronic evaluation device 20, which serves to determine whether or not the pharmaceutical product 1 has the desired properties on the basis of the recorded or acquired image of the X-ray radiation. For this purpose, it may also be provided that in the beam path
• a reference object not shown in the figure, is arranged, which serves for comparison with the respective pharmaceutical product 1 to be screened.
• the detector 18 thus simultaneously, d. H. with a single image, both the pharmaceutical product 1, as well as the reference object transilluminated or detected.
• the feeding device 15 has a constant, in particular a rectangular cross-section, at least at the level of the X-ray source 17, but preferably over the entire vertical length thereof.
• the cross-section or the cross-sectional area of the feed device 15 is dimensioned such that it is larger than the cross sections of the pharmaceutical products to be examined 1.
• the detector 18 forms in the illustrated embodiment, on the side facing away from the X-ray source 17 side of a wall portion of the feeder 15, in that the feed device 15 has a corresponding recess or recess in the region of the detector 18.
• this On the detector 18 opposite side of the feeder 15, this has a further recess 23 in which a pivotable in the direction of the double arrow 24 locking flap 25 is arranged.
• the movable by means of a drive not shown locking flap 25 is mounted in a horizontally arranged axis of rotation 26 which is arranged in the region of the recess 23 and has a length which is greater than the length of the pharmaceutical products 1, to pivot a flat support surface form for the pharmaceutical product 1 or to prevent jamming of the pharmaceutical see product 1 in the feeder 15 in the blocking position of the locking flap 25.
• the blocking flap 25, which consists of a material that is permeable to the X-ray source 17, terminates flush with the wall of the feeding device 15 in its releasing position.
• the lower edge 29 of the blocking flap 25 facing away from the axis of rotation 26 touches the detector 18 or the wall of the feeding device 15 (the latter not shown), or is arranged at such a small distance therefrom the pharmaceutical product 1 can not fall through the gap formed thereby.
• the irradiation of the pharmaceutical product 1 by means of the X-ray source 17 takes place.
• the longitudinal axis 30 of the pharmaceutical product 1 during the measurement or during the irradiation at an oblique angle to the longitudinal axis 31 of the arranged in vertical alignment feeder 15, and arranged in an oblique Wnkel to the beam axis 32 of the X-ray source 17 is.
• the blocking flap 25 forms a bearing surface for the pharmaceutical product 1.
• the mentioned reference object is arranged in an identical angular position to the blocking flap 25 as the pharmaceutical product 1 when the blocking flap 25 is in its locking position.
• two further blocking flaps 34, 35 are arranged, which are formed substantially identical to the blocking flap 25, but for example need not consist of a permeable to the X-ray source 17 material.
• the other barrier flaps 34, 35 are controlled by means not shown drives, in particular individually.
• a flap 38 which is arranged pivotably in an axis of rotation 37, is arranged, which is part of an separating device 40.
• the separating device 40 controlled in particular by the evaluating device 20 pivots the flap 38 into one or the other position according to the direction of the double arrow 41, so that pharmaceutical products 1 recognized as "good” have another further conveying path undergo "bad” recognized pharmaceutical products 1.
• the capsule control device 10 described so far operates as follows: By means of the delivery wheel 12, in each case a pharmaceutical product 1 is released from the conveyor wheel 12 into the feed device 15. It falls as a result of its weight in the area of the blocking flap 25.
• the blocking flap 25 is located initially in its locked position. After the pharmaceutical product 1 lies on the blocking flap 25, it is transilluminated by means of the X-ray source 17, wherein the image detected by the detector 18, together with the image of the reference object, is supplied to the evaluation device 20. Subsequently, the blocking flap 25 is pivoted into its releasing position, so that the pharmaceutical product 1 can subsequently be conveyed in several stages via the further blocking flaps 34, 35 in the direction of the outlet 36 of the feeding device 15.
• the capsule control device 10 described so far can be modified or modified in many ways, without deviating from the idea of the invention.
• other feeding devices instead of the conveying wheel 12 or other separating devices 40 are also conceivable.

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• Health & Medical Sciences (AREA)
• Physics & Mathematics (AREA)
• General Physics & Mathematics (AREA)
• General Health & Medical Sciences (AREA)
• Life Sciences & Earth Sciences (AREA)
• Chemical & Material Sciences (AREA)
• Engineering & Computer Science (AREA)
• Analytical Chemistry (AREA)
• Immunology (AREA)
• Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
• Multimedia (AREA)
• Biochemistry (AREA)
• Toxicology (AREA)
• Veterinary Medicine (AREA)
• Radiology & Medical Imaging (AREA)
• Pathology (AREA)
• Medicinal Chemistry (AREA)
• Pharmacology & Pharmacy (AREA)
• Animal Behavior & Ethology (AREA)
• Public Health (AREA)
• General Engineering & Computer Science (AREA)
• High Energy & Nuclear Physics (AREA)
• Analysing Materials By The Use Of Radiation (AREA)

Applications Claiming Priority (2)

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• 2011
  • 2011-04-13 DE DE102011007269A patent/DE102011007269A1/de not_active Withdrawn
• 2012
  • 2012-03-01 CN CN201280017764.0A patent/CN103476678B/zh not_active Expired - Fee Related
  • 2012-03-01 US US14/111,570 patent/US9368246B2/en not_active Expired - Fee Related
  • 2012-03-01 EP EP12707537.2A patent/EP2697120A1/de not_active Withdrawn
  • 2012-03-01 WO PCT/EP2012/053572 patent/WO2012139812A1/de active Application Filing
  • 2012-03-01 JP JP2014504222A patent/JP2014515104A/ja active Pending

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