Detection and characterization of defects in pharmaceutical cylindrical containers

Abstract

To provide a device for quickly, variably and reliably inspecting cylindrical medicine containers. An apparatus for inspecting a polymeric medication cylinder (2) includes a support device (1), a light receiving unit (3), and a light emitting unit (4). The support device supports the medication cylinder such that the medication cylinder is rotatable about its longitudinal axis (12). The light emitting unit includes a light source (5) and is configured to illuminate the medication cylinder with an inspection beam, and the light receiving unit includes a camera (8) and is configured to receive light emitted by the medication cylinder to obtain an image of at least a portion of the medication cylinder.

Description

[Technical Field]

[0001] The present invention relates to a specific apparatus for inspecting polymeric pharmaceutical cylinders, which includes a support device, a light receiving unit and a light emitting unit.

[0002] Additionally, the present invention relates to a specific method for inspecting polymeric pharmaceutical cylinders.

[0003] Additionally, the present invention relates to an improved bundle of polymeric medication cylinders. [Background technology]

[0004] For quality assurance purposes, it is common practice to inspect finished pharmaceutical cylinders or intermediate pharmaceutical cylinders during the manufacturing process, and if a defect is detected, the finished product or intermediate product can be removed from further processing.

[0005] An apparatus for inspecting glass panes is known from DE 102011113670. Furthermore, DE 102016114190 A1 discloses a method and a device for the optical inspection of transparencies.

[0006] In particular, pharmaceutical cylinders such as syringes, cartridges, and vials must meet strict quality standards. For example, pharmaceutical cylinders containing defects such as slides, bulges, dents, scratches, attached particles, bubbles, or trapped foreign bodies must be avoided. Because pharmaceutical cylinders are mass-produced, inspection systems must be developed that can measure pharmaceutical cylinders very quickly. Nevertheless, it must be guaranteed that pharmaceutical cylinders containing any defects can be reliably identified and excluded from further processing. Furthermore, some defects cannot be visualized using normal optical systems. In particular, optical defects such as slides are usually not easy to detect.

[0007] Known devices for testing pharmaceutical cylinders do not meet the above requirements in terms of fast, variable and reliable testing. Summary of the Invention [Problem to be solved by the invention]

[0008] The invention described herein addresses the problem of improving and further developing an apparatus and method for inspecting polymeric medication cylinders so that inspection is rapid and reliable. Additionally, the invention relates to an improved bundle of polymeric medication cylinders. [Means for solving the problem]

[0009] In one embodiment, the present invention provides an apparatus for inspecting a polymeric medication cylinder, the apparatus including a support device, a light receiving unit, and a light emitting unit. The support device supports the medication cylinder such that the medication cylinder is rotatable about its longitudinal axis. The light emitting unit includes a light source and is configured to illuminate the medication cylinder with an inspection beam, and the light receiving unit includes a camera and is configured to receive light emitted by the medication cylinder to obtain an image of at least a portion of the medication cylinder.

[0010] In another embodiment, the present invention advantageously provides a method of inspecting polymeric pharmaceutical cylinders using the apparatus described herein, the method comprising: - illuminating the medication cylinder with a light emitting unit; receiving light emitted by the medicine cylinder by a light receiving unit to obtain an image of the medicine cylinder; characterizing defects in and / or on the pharmaceutical cylindrical container based on the obtained images; Contains:

[0011] In another embodiment, the present invention provides a bundle of polymeric drug cylinders, advantageously inspected by the apparatus and / or methods described herein, the bundle comprising 10 or more drug cylinders, advantageously 10 to 1000 drug cylinders, more advantageously 20 to 500 drug cylinders, and most advantageously 40 to 250 drug cylinders; the medicament cylinder exhibits a value Y of about 0.5 or less, advantageously 0.4 or less, more advantageously 0.3 or less, more advantageously 0.2 or less, more advantageously 0.1 or less, more advantageously 0.05 or less, more advantageously 0.01 or less, in the formula Y=A / B, where A is the maximum length in cm of any slide in the cylindrical portion of the medicament cylinder, and B is the length in cm of the cylindrical portion of the medicament cylinder; and / or The pharmaceutical cylinder exhibits a value Z of about 0.5 or less, advantageously 0.4 or less, more advantageously 0.3 or less, more advantageously 0.2 or less, more advantageously 0.1 or less, more advantageously 0.05 or less, and more advantageously 0.01 or less, in the formula Z=A / B, where A is the area, in cm, of the slide in the cylindrical portion of the pharmaceutical cylinder. 2 B is the area, in cm, of the cylindrical part of the drug cylindrical container. 2 The area is

[0012] An advantage of the present invention is that by acquiring an image based on the light emitted by the pharmaceutical cylindrical container, specific or even very small optical defects of slides, etc. can be visualized and therefore detected. Furthermore, by using the light emitted by the container as a feature to distinguish them from other defect classes, the classification of the defects is optimized.

[0013] The term "medicinal cylinder," particularly in the claims and advantageously in the description, refers to a cylinder usable for storing pharmaceutical products, such as injection solutions or tablets. A pharmaceutical cylinder may be a syringe, a vial, an ampoule, a cartridge, or any specialized article of tubing containing at least a cylindrical portion. Therefore, a container does not have to be entirely cylindrical to be a pharmaceutical cylinder. The diameter of the cylindrical portion of a pharmaceutical cylinder inspected by the device of the present invention may be in the range of 4 mm to 80 mm, advantageously 6 mm to 50 mm. Advantageously, the device includes one pharmaceutical cylinder. Advantageously, the pharmaceutical cylinder is manufactured by injection molding, i.e., it is advantageously an injection-molded pharmaceutical cylinder. Injection molding is an inexpensive and reliable method for manufacturing polymeric pharmaceutical cylinders.

[0014] The term "longitudinal axis", particularly in the claims and advantageously in the description, refers to a line running from the bottom to the top of the cylindrical portion of the drug cylindrical container, particularly the axis of rotation. The diameter of the cylindrical portion of the drug cylindrical container to be measured may be determined by a support device. This support device supports the drug cylindrical container when the drug cylindrical container is not present in the apparatus. For example, when the support device supports the drug cylindrical container on its side, the support device may include three wheels that support the drug cylindrical container, and the circumference of the drug cylindrical container may be determined by these three wheels.

[0015] In the present application, a "medicinal cylindrical container" includes at least a cylindrical portion. Therefore, a pharmaceutical cylindrical container, such as a syringe, cartridge, or ampoule, that includes a non-cylindrical terminal end is a pharmaceutical cylindrical container. In the present application, the side surface of the pharmaceutical cylindrical container does not need to be smooth. The side surface may include grooves, ridges, corrugations, or any other structure. Furthermore, the side surface may have a wavy shape or any other shape, as long as the pharmaceutical cylindrical container presents a longitudinal axis and is rotatable about the longitudinal axis.

[0016] In this application, a bundle is a trading, loading, or packaging unit for distribution of pharmaceutical cylinders. For example, products of the same type are usually combined into a bundle when ordered together at a retail store or bundled for logistics. In the present invention, the pharmaceutical cylinders of the bundle can be separated by a spacer, such as a plastic or paper sheet, or can be placed in a holding device, such as a nest or tub, so that they do not come into contact with each other during transportation. Usually, but not necessarily, the bundle is at least partially covered with a plastic film. Preferably, one bundle is covered with a plastic film, and more preferably, the bundle is covered with a plastic film and all the pharmaceutical cylinders are sterilized, for example, by steam sterilization or gamma radiation. For economic reasons, the spacing between two cylinders in the bundle is preferably less than 5 mm, more preferably less than 3 mm, more preferably less than 1 mm, and even more preferably less than 0.5 mm, and most preferably, the cylinders are in direct contact with each other to further reduce the size and weight of the bundle. A bundle typically contains 10 or more, preferably 10 to 1000, more preferably 20 to 500, and most preferably 40 to 250 pharmaceutical cylinders. An example of a bundle is the iQ™ platform, i.e., SCHOTT AG's ready-to-use platform cartriQ™, adaptiQ®, or syriQ®. One or more, preferably 10 to 50, bundles can be stacked on a pallet or packed into a separate box for shipping. Thus, in one embodiment, a shipping box contains one or more, preferably 5 to 50, more preferably 10 to 25, bundles described herein.

[0017] The term "emitted", in relation to a pharmaceutical cylinder, in particular in the claims and preferably in the description, refers to light emitted by the pharmaceutical cylinder after absorption of photons resulting from illumination of the container by light from a light source, i.e. photoluminescence, preferably fluorescence and / or phosphorescence.

[0018] In the present invention, the drug cylinder is made of a polymer. In an advantageous embodiment, the drug cylinder is made of a cyclic olefin copolymer (COC) or a cyclic olefin polymer (COP), more advantageously a cyclic olefin copolymer (COC). The advantages of these materials are that they meet the requirements for use in the field of drug containers and that they are easy to handle. Furthermore, defects in these materials, i.e., slides, etc., in this material are detectable, for example, due to fluorescence and / or phosphorescence.

[0019] In this application, a slide is a portion of the material of a pharmaceutical cylinder that, when illuminated with light, preferably UV light, appears brighter in the visible range compared to the rest of the material, i.e., emits light; scattered or reflected light is not emitted light. The length and area of ​​the slide can be calculated as follows:

[0020] An image of the emitted light of the cylindrical portion of the drug cylinder is taken, which is neither overexposed nor underexposed. Those skilled in the art will know how to take this type of image. The entire cylindrical portion of the drug cylinder is taken in at least 1000, e.g., 1*10 6The image is acquired by pixels. Between each image acquisition, the medicine cylinder is rotated by a certain angle, for example 5°, thereby obtaining a 360° view of the cylindrical part of the medicine cylinder. The dynamic range of the sensor is 1:100 or more, for example 1:256. The darkest point of the acquired image should be set to 10% of the total number of the dynamic range, for example, if the dynamic range is 1:100, the darkest point should be set to a value of 10 (=10% of 100). The pixel representing the slide is a pixel having a value of 50% or more within the range of the dynamic range, for example, if the dynamic range is 1:100, the pixel representing the slide is a pixel having a value of 50 (=50% of 100) or more within the range of the dynamic range. Advantageously, the image is a black and white image in the visible range of the electromagnetic spectrum. Advantageously, the image is acquired by a Basler camera acA1920-155um equipped with a Sony sensor IMX174 CMOS.

[0021] Supported Devices In the present invention, the apparatus includes a support device, which supports the medication cylinder such that the medication cylinder is rotatable about its longitudinal axis.

[0022] In an advantageous embodiment, the support device supports the medicament cylinder on its side or at its end. In an advantageous embodiment, the support device supports the medicament cylinder on its end, where the support device does not contact the cylindrical portion of the medicament cylinder. This can be achieved, for example, by supporting the medicament cylinder on the neck of a vial or the flange of a syringe, i.e., by inserting the medicament cylinder into a socket in the support device. This type of support device is advantageous for objects such as vials, cartridges, syringes, etc., which include an end having a different diameter than the cylindrical portion of the container. In another embodiment, the support device supports the medicament cylinder on its side. Supporting the medicament cylinder on its side is advantageous because the container is held securely and can be rotated accurately about its longitudinal axis (see European Patent Applications 19200246.7 and 19200221.0).

[0023] Light-emitting unit In the present invention, the device includes a light emitting unit, which includes a light source and is configured to illuminate the medication cylinder with an inspection beam.

[0024] In an advantageous embodiment, the light source emits light comprising a wavelength in the range of 10 nm to 1000 nm, advantageously 100 nm to 400 nm, more advantageously 220 nm to 380 nm. The use of such a light source has the advantage that the photoluminescence of the pharmaceutical cylinder is stimulated so that defects in the pharmaceutical cylinder, such as slides or small defects, can be identified.

[0025] In an advantageous embodiment, the light source is an ultraviolet gas discharge lamp and / or an ultraviolet light emitting diode and / or an ultraviolet laser, advantageously an ultraviolet light emitting diode and / or an ultraviolet laser, which have the advantage that they emit ultraviolet light that is used to stimulate the photoluminescence of the pharmaceutical cylinder.

[0026] In an advantageous embodiment, the device comprises two or more, advantageously 2 to 20, more advantageously 5 to 18, light-emitting units, each comprising a light source. The light-emitting units may have different wavelengths and / or intensities and / or sizes, and may have different polarizations of light. In an advantageous embodiment, the device comprises a light-emitting unit comprising a light source and configured to illuminate the pharmaceutical cylinder with a linearly polarized or unpolarized inspection beam, advantageously with a linearly polarized inspection beam, and more advantageously, the device comprises a second light-emitting unit comprising a light source and configured to illuminate the pharmaceutical cylinder with an inspection beam, advantageously with a linearly polarized or unpolarized inspection beam, advantageously with a unpolarized inspection beam. The use of different polarizations makes it easier to distinguish the emitted light from scattered or transmitted light.

[0027] Light receiving unit In the present invention, the device includes a light receiving unit, which includes a camera and is configured to receive light emitted by the medicine cylinder to obtain an image of at least a portion of the medicine cylinder, advantageously the entire medicine cylinder.

[0028] In an advantageous embodiment, the light received by the light receiving unit comprises wavelengths in the range of 300 nm to 700 nm, advantageously 400 nm to 500 nm, more advantageously 430 nm to 460 nm. By using a light receiving unit configured to receive and advantageously distinguish light of the aforementioned wavelengths, it is possible to detect a wide range of light emitted by the pharmaceutical cylindrical container due to photoluminescence, e.g. fluorescence and / or phosphorescence, and to obtain an image of at least a part of the container.

[0029] In an advantageous embodiment, the light receiving unit comprises a camera and a lens, wherein the lens is transparent to light having a wavelength in the range of 200 nm to 900 nm, advantageously 400 nm to 800 nm, more advantageously 400 nm to 500 nm, and more advantageously 430 nm to 460 nm.

[0030] In an advantageous embodiment, the light receiving unit comprises a filter that blocks light having a wavelength of 600 nm or more, advantageously 500 nm or more, more advantageously 460 nm or more, and / or light having a wavelength of 200 nm or less, advantageously 300 nm or less, more advantageously 400 nm or less, more advantageously 430 nm or less.

[0031] In an advantageous embodiment, the device includes a polarizer, more advantageously located between the medication cylinder and the light receiving unit. In another advantageous embodiment, the light receiving unit includes a polarization camera. In certain configurations, such as those involving illumination with linearly polarized light (see above), this makes it possible to easily distinguish emitted light from scattered or transmitted light.

[0032] arrangement Advantageously, the light source is a top light, which has the advantage that defects on the front side of the cylinder, i.e. on the wall facing the receiving unit, can be easily visualized and detected with greater precision.

[0033] In advantageous embodiments, the longitudinal axis of the medicament cylindrical container and a horizontal axis perpendicular to the longitudinal axis define a horizontal plane, wherein the centre line of the camera intersects with the horizontal plane at an angle of between 0° and 30°, advantageously between 0° and 20°, more advantageously between 0° and 10°, and most advantageously at an angle of about 0°; and / or the longitudinal axis of the medicament cylindrical container and a vertical axis perpendicular to the longitudinal axis define a vertical plane, wherein the centre line of the camera intersects with the vertical plane at an angle of between 60° and 90°, advantageously between 70° and 90°, more advantageously between 80° and 90°, and most advantageously at an angle of about 90°; and / or A horizontal axis perpendicular to the longitudinal axis of the medication cylindrical container and a vertical axis perpendicular to the longitudinal axis and intersecting the center of the cylindrical portion of the medication cylindrical container define a transverse plane, wherein the centerline of the camera intersects the transverse plane at an angle of between 0° and 30°, preferably between 0° and 20°, more preferably between 0° and 10°, and most preferably at an angle of about 0°.

[0034] In an advantageous embodiment, the longitudinal axis of the medicament cylindrical container and a horizontal axis perpendicular to the longitudinal axis define a horizontal plane, and the centre line of the camera and / or the centre line of the light source, advantageously the centre line of the camera and the centre line of the light source, intersect with the horizontal plane at an angle of between 0° and 50°, advantageously at an angle of between 0° and 30°, more advantageously at an angle of between 0° and 20°, even more advantageously at an angle of between 0° and 10°, most advantageously at an angle of about 0°; and / or the longitudinal axis of the medicament cylindrical container and a vertical axis perpendicular to the longitudinal axis define a vertical plane, wherein the centre lines of the camera and / or light source, advantageously the centre lines of the camera and light source, intersect with the vertical plane at an angle of between 45° and 90°, advantageously between 60° and 90°, advantageously between 70° and 90°, more advantageously between 80° and 90°, and most advantageously at an angle of about 90°; and / or A horizontal axis perpendicular to the longitudinal axis of the medicament cylindrical container and a vertical axis perpendicular to the longitudinal axis and intersecting the center of the cylindrical portion of the medicament cylindrical container define a transverse plane, wherein the center line of the camera and / or the center line of the light source, preferably the center line of the camera and the center line of the light source, intersect with the transverse plane at an angle of 0° to 50°, advantageously at an angle of 0° to 30°, advantageously at an angle of 0° to 50°, advantageously at an angle of 0° to 30°, advantageously at an angle of 0° to 20°, more advantageously at an angle of 0° to 10°, and most advantageously at an angle of about 0°.

[0035] In an advantageous embodiment, the centerline of the camera and / or the centerline of the light source, advantageously the centerline of the camera and the centerline of the light source, are in contact with the drug cylindrical container, advantageously the central region of the drug cylindrical container, more advantageously the center of the cylindrical portion of the drug cylindrical container.

[0036] In an advantageous embodiment, the device comprises a light emitting unit A, a light receiving unit B and a light receiving unit C, wherein the light emitting unit A comprises a light source A and is configured to illuminate the medicine cylindrical container with an inspection beam, the light receiving unit B comprises a camera B and is advantageously configured to receive light emitted by the medicine cylindrical container illuminated by the light emitting unit A in order to obtain an image of at least a part of the medicine cylindrical container, and the light receiving unit C comprises a camera C and is advantageously configured to receive light scattered by and / or light transmitted through the medicine cylindrical container illuminated by the light emitting unit A in order to obtain an image of at least a part of the medicine cylindrical container.

[0037] This arrangement can be realized, for example, when the light source A is arranged on the opposite side of the medicine cylinder from the light receiving unit C and the light source A is top-lighted with respect to the light receiving unit B. This allows a compact arrangement of the light sources and the cameras, and more cameras, for example 10 or more, advantageously 10 to 25 cameras, can be incorporated into the device. Furthermore, the inspection time can be shortened, because both (types of) images can be acquired by acquiring one light source.

[0038] method In another embodiment, the present invention provides a method for inspecting polymeric pharmaceutical cylinders using an apparatus according to any one of claims 1 to 10, the method comprising: - illuminating the medication cylinder with a light emitting unit; receiving light emitted by the medicine cylinder by a light receiving unit to obtain an image of the medicine cylinder; characterizing defects in and / or on the pharmaceutical cylindrical container based on the obtained images; Contains:

[0039] This method makes it possible to detect irregularities in pharmaceutical cylindrical containers, such as slides. Furthermore, even very small defects can be visualized and characterized. One reason for this may be that the polymer forms differently around small defects, and the differently shaped areas of the polymer are much larger than the defect itself and are visible in the image showing the emitted light of the container, so that even defects below the lower detection limit of the camera of the light receiving unit can be detected. Furthermore, the present inventors have surprisingly found that the possibility of detecting and characterizing certain types of defects, such as slides or very small defects, can be significantly improved if the defect is characterized by comparing the image showing the emitted light of the container with the image showing the scattered light and / or transmitted light.

[0040] Thus, in an advantageous embodiment, the method further comprises: - illuminating the medicament cylinder with the same light-emitting unit and / or another light-emitting unit; receiving, by the same light receiving unit or by a different light receiving unit, advantageously by a different light receiving unit, light scattered by and / or transmitted through the medicine cylinder, advantageously illuminated by the same light emitting unit, in order to obtain an image of the medicine cylinder; characterizing defects in and / or on the pharmaceutical cylinder based on the obtained images. Contains:

[0041] The same or different light-emitting units can be used to achieve the above-described illumination. Furthermore, the wavelength of light used in the device described herein can be distinguished from the wavelength of light used to implement the method described herein. By receiving and analyzing light scattered by and / or transmitted through the pharmaceutical cylinder, other defects, such as cracks, can be visualized. Pharmaceutical cylinders, particularly those made of COC or COP, are typically manufactured by injection molding, which can result in the formation of multiple slides. The total number and size of slides are related to many factors, such as temperature and injection speed. Even under extremely favorable conditions, the formation of slides cannot be suppressed, and slides can extend over the entire length of the cylindrical portion of the pharmaceutical cylinder. Furthermore, using conventional techniques, many slides can be formed that extend over an extremely large area of ​​the cylindrical portion of the pharmaceutical cylinder. In summary, the process / conditions for the formation of slides in polymers are not fully understood. Therefore, since the formation, size and total number of slides cannot be predicted, it is only possible to ascertain whether a pharmaceutical cylinder will present a particular slide or area of ​​slides by inspection of the cylinder after manufacture.

[0042] In an advantageous embodiment, the image is analyzed to detect slides in the polymer of the pharmaceutical cylinder, and / or the image is analyzed to optimize and / or control the process for manufacturing the pharmaceutical cylinder, and / or If the medicament cylinder exhibits a value of Y of about 1.0, advantageously between 0.9 and 1.0, more advantageously between 0.8 and 1.0, more advantageously between 0.7 and 1.0, more advantageously between 0.6 and 1.0, more advantageously between 0.5 and 1.0, more advantageously between 0.4 and 1.0, more advantageously between 0.3 and 1.0, more advantageously between 0.2 and 1.0, more advantageously between 0.1 and 1.0, more advantageously between 0.05 and 1.0, this medicament cylinder is excluded from further processing, in the formula Y=A / B, where A is the maximum length in cm of any slide in the cylindrical part of the medicament cylinder, and B is the length in cm of the cylindrical part of the medicament cylinder, and / or If the medication cylinder exhibits a value of Z in the formula Z=A / B of about 1.0, preferably 0.9-1.0, more preferably 0.8-1.0, more preferably 0.7-1.0, more preferably 0.6-1.0, more preferably 0.5-1.0, more preferably 0.4-1.0, more preferably 0.3-1.0, more preferably 0.2-1.0, more preferably 0.1-1.0, more preferably 0.05-1.0, this medication cylinder is excluded from further processing, where A is the area of ​​the slide in cm 2 B is the area, in cm, of the cylindrical part of the drug cylindrical container. 2 The area is

[0043] bundle In another embodiment, the present invention advantageously provides a bundle of polymeric pharmaceutical cylinders inspected by the apparatus and / or methods described herein, the bundle comprising 10 or more, advantageously 10-1000, more advantageously 20-500, and most advantageously 40-250 pharmaceutical cylinders, the pharmaceutical cylinders exhibiting a value of Y of about 0.5 or less, advantageously 0.4 or less, more advantageously 0.3 or less, more advantageously 0.2 or less, more advantageously 0.1 or less, more advantageously 0.05 or less, and more advantageously 0.01 or less, in the formula Y=A / B, where A is the maximum length, in cm, of any slide in the cylindrical portion of the pharmaceutical cylinder, and B is the length, in cm, of the cylindrical portion of the pharmaceutical cylinder.

[0044] In another embodiment, the present invention advantageously provides a bundle of polymeric medication cylinders inspected by the apparatus and / or methods described herein, wherein the bundle comprises 10 or more, advantageously 10-1000, more advantageously 20-500, and most advantageously 40-250 medication cylinders, the medication cylinders exhibiting a value of Z of about 0.5 or less, advantageously 0.4 or less, more advantageously 0.3 or less, more advantageously 0.2 or less, more advantageously 0.1 or less, more advantageously 0.05 or less, and more advantageously 0.01 or less, in the formula Z=A / B, where A is the area, in cm, of the slide in the cylindrical portion of the medication cylinder. 2 B is the area, in cm, of the cylindrical part of the drug cylindrical container. 2 The area is

[0045] In an advantageous embodiment, the medication cylinder exhibits the values ​​Y and Z described above.

[0046] This type of pharmaceutical cylinder bundle meets the highest quality standards for products used in medical packaging. The slides can affect testing of the pharmaceutical compositions inserted into the pharmaceutical cylinders. This can occur, for example, if the slides interfere with testing systems that use UV light to detect impurities in the pharmaceutical compositions.

[0047] Thus, the chances of subsequent processing of pharmaceutical cylinders containing pharmaceutical compositions containing any impurities are minimized using the apparatus and / or methods described herein.

[0048] Another embodiment provides an apparatus for inspecting polymeric medication cylinders, wherein the apparatus is configured to inspect the medication cylinder in 1 second or less, advantageously 0.9 seconds or less, more advantageously 0.8 seconds or less, more advantageously between 0.6 and 0.9 seconds, advantageously between 0.7 and 0.8 seconds; and / or the device is configured to be capable of detecting slides exhibiting a value of Y of about 0.5 or less, advantageously 0.4 or less, more advantageously 0.3 or less, more advantageously 0.2 or less, more advantageously 0.1 or less, more advantageously 0.05 or less, and more advantageously 0.01 or less, in the formula Y=A / B, where A is the maximum length in cm of any slide in the cylindrical portion of the medication cylinder, and B is the length of the cylindrical portion of the medication cylinder; and / or The device is configured to be capable of detecting slides exhibiting a value of Z of about 0.5 or less, preferably 0.4 or less, more preferably 0.3 or less, more preferably 0.2 or less, more preferably 0.1 or less, more preferably 0.05 or less, and more preferably 0.01 or less, in the formula Z=A / B, where A is the area, in cm, of the slide in the cylindrical portion of the medication cylinder. 2 B is the area, in cm, of the cylindrical part of the drug cylindrical container. 2 The area is

[0049] There are several ways in which the teaching of the present invention can be advantageously designed and further developed. For this, reference should be made on the one hand to the claims dependent on claims 1, 11 and 14, and on the other hand to the following description of advantageous examples of embodiments of the present invention shown in the figures. In connection with the description of advantageous embodiments of the present invention using the figures, generally advantageous embodiments and further developments of the teaching will be illustrated in the figures. [Brief explanation of the drawings]

[0050] [Figure 1] 1 shows a schematic cross-sectional view of an apparatus according to an embodiment of the present invention; [Figure 2] 1 shows a schematic cross-sectional view of an apparatus according to another embodiment of the present invention. [Figure 3] 1 shows a schematic cross-sectional view of an embodiment of a support device of the present invention. [Figure 4] Schematic diagrams of horizontal, vertical and cross sections are shown. [Figure 5] 1 shows a schematic block diagram of a method of an embodiment of the present invention; DETAILED DESCRIPTION OF THE INVENTION

[0051] In the following description of the embodiments, the same reference numbers refer to similar components.

[0052] 1 shows an apparatus according to an embodiment of the present invention, which comprises a support device 1 for a medication cylinder 2, a light receiving unit 3 and a light emitting unit 4.

[0053] The light-emitting unit 4 includes a light source 5 for illuminating the medication cylinder 2 arranged on the support device 1. Light 6 emitted by the medication cylinder 2, i.e., photoluminescence light, e.g., phosphorescence and fluorescence, is received by the light-receiving unit 3. In this embodiment, the light-receiving unit 3 includes a lens 7 and a camera 8. Thus, an image of at least a portion of the medication cylinder 2 can be acquired by the camera 8, and defects, e.g., slides, can be identified on this image. In an advantageous embodiment, the light source 5 is an ultraviolet light source, the lens 7 is transparent to light having a wavelength of at least 430 nm to 460 nm, and the camera 8 is a camera capable of detecting light in the visible region of the electromagnetic spectrum, e.g., a Basler acA1920-155um camera equipped with a Sony IMX174 CMOS sensor.

[0054] Figure 2 shows a schematic cross-sectional view of an apparatus according to another embodiment of the present invention. The apparatus shown in Figure 2 corresponds to the apparatus shown in Figure 1, but the light receiving unit 3 further includes a filter 18. In an advantageous embodiment, the filter 18 selectively blocks light having a wavelength of 200 nm or less and 600 nm or more, advantageously 300 nm or less and 500 nm or more, more advantageously 300 nm or less and 460 nm or more, and even more advantageously 300 nm or less and 430 nm or more.

[0055] With the exception of the filter 18 and the arrangement of the light emitting and receiving units, the embodiment of Figure 2 corresponds to the embodiment of Figure 1. Therefore, reference is now made to the description of Figure 1, which applies equally to Figure 2.

[0056] FIG. 3 is used to illustrate an embodiment of a support device 1 of the apparatus of the present invention, without considering any limitations regarding the embodiment shown. The support device 1 includes a first support wheel 9 and a second support wheel 10, by which a container 2 is supported. As can be seen, a rotation axis 11 of the first support wheel 9 and a longitudinal axis 12 of the container 2 define a first plane 13. Furthermore, a rotation axis 14 of the second support wheel 10 and the longitudinal axis 12 of the container 2 define a second plane 15. The first plane 13 and the second plane 15 intersect at an angle 16. In an advantageous embodiment, the angle 16 is in the range of 45° to 120° or less, preferably 50° to 90°, more preferably 60° to 80°, even more preferably 65° to 75°, and most preferably approximately 70°. Those skilled in the art will understand that the position of the longitudinal axis 12 is related to the diameter of the container 2. Therefore, if the apparatus is to be used for a container 2 having a different diameter, the positions of the first support wheel 9 and the second support wheel 10 must be adapted. Furthermore, a friction wheel 17 is arranged above the support device 1 so that the container 2 can rotate about its longitudinal axis 12. A top light is advantageously used (not shown) to illuminate the pharmaceutical cylindrical container.

[0057] 4 shows a medication cylinder 2 and its longitudinal axis 12. The longitudinal axis 12 and a perpendicular horizontal axis define a horizontal plane 18. Furthermore, the longitudinal axis 12 of the medication cylinder 2 and a vertical axis perpendicular to the longitudinal axis define a vertical plane 19. Furthermore, the horizontal axis perpendicular to the longitudinal axis 12 of the medication cylinder 2 and a vertical axis perpendicular to the longitudinal axis and intersecting the center of the cylindrical portion of the medication cylinder define a cross-section 20.

[0058] 5 shows a block diagram of an embodiment of this method. The method is used for inspecting a pharmaceutical cylinder 2 made of polymer. In a first step 21, the pharmaceutical cylinder 2 is illuminated by a light emitting unit 4. In a second step 22, light 6 emitted by the pharmaceutical cylinder 2 is received by a light receiving unit 3 to acquire an image of the pharmaceutical cylinder 2. In a third step 23, defects in and / or on the pharmaceutical cylinder 2 are characterized based on the acquired image. Further steps can be performed, for example, analyzing the image to detect slides in the pharmaceutical cylinder 2 and / or analyzing the image to optimize and / or control the process for manufacturing the pharmaceutical cylinder 2 and / or excluding the pharmaceutical cylinder 2 from further processing if slides having at least a predetermined length are detected. A further step may be to illuminate the pharmaceutical cylindrical container, preferably by means of a further light-emitting unit, then receive light scattered by and / or transmitted through the pharmaceutical cylindrical container, preferably by means of a further light-receiving unit, in order to obtain an image of the pharmaceutical cylindrical container, and then characterize defects in and / or on the pharmaceutical cylindrical container based on the obtained image.

[0059] Many modifications and other embodiments of the inventions described herein will come to mind to one skilled in the art to which these inventions pertain having the benefit of the teachings presented in the foregoing descriptions and the associated drawings. It is to be understood, therefore, that the invention is not to be limited to the specific embodiments disclosed, and that modifications and other embodiments are intended to be included within the scope of the appended claims. Although specific terms are employed herein, they are used in a generic and descriptive sense only and not for purposes of limitation. [Explanation of symbols]

[0060] 1. Supported Devices 2 containers 3 Light receiving unit 4 Lighting Unit 5 light source 6 Emitted Light 7 Lenses 8. Camera 9 First Support Wheel 10 Second Support Wheel 11 Rotation axis (first support wheel) 12 Longitudinal axis (container) 13 First Side 14 Rotation axis (second support wheel) 15 Second Side 16 angles 17 Friction Wheel 18 horizontal plane 19 Vertical plane 20 cross section 21 First Step 22 Second Step 23 Third Step

Claims

1. 1. An apparatus for inspecting polymeric medication cylinders, comprising: The apparatus includes a support device, a light-receiving unit, and a light-emitting unit; the support device supports the medication cylinder such that the medication cylinder is rotatable about its longitudinal axis; the light emitting unit includes a light source and is configured to illuminate the medication cylinder with an inspection beam; the light receiving unit includes a camera and is configured to receive light emitted by the medication cylinder to capture an image of at least a portion of the medication cylinder. Device.

2. the light source emits light comprising wavelengths in the range of 10 nm to 1000 nm, preferably 100 nm to 400 nm, more preferably 220 nm to 380 nm; 10. The apparatus of claim 1.

3. the light source is an ultraviolet gas discharge lamp and / or an ultraviolet light-emitting diode and / or an ultraviolet laser, preferably an ultraviolet light-emitting diode and / or an ultraviolet laser, 3. The device according to claim 1 or 2.

4. the light receiving unit is configured to receive light emitted by the medicament cylindrical container, the light having a wavelength in the range of 300 nm to 700 nm, preferably 400 nm to 500 nm, more preferably 430 nm to 460 nm.

4. An apparatus according to any one of claims 1 to 3.

5. the device includes a medication cylinder; In the formula X=B−A, B is the maximum wavelength of light emitted by the medication cylinder; A is the maximum wavelength emitted by the light source of the light-emitting unit; X is in the range of 50 nm to 500 nm, preferably 75 nm to 500 nm, more preferably 100 nm to 300 nm; 5. An apparatus according to any one of claims 1 to 4.

6. The light receiving unit includes a camera and a lens, and the lens is transparent to light having a wavelength in the range of 200 nm to 900 nm, preferably 400 nm to 800 nm, more preferably 400 nm to 500 nm, and more preferably 430 nm to 460 nm.

6. An apparatus according to any one of claims 1 to 5.

7. the light receiving unit includes a filter that blocks light having a wavelength of 600 nm or more, preferably 500 nm or more, more preferably 460 nm or more, and / or light having a wavelength of 200 nm or less, preferably 300 nm or less, more preferably 400 nm or less, more preferably 430 nm or less; 7. An apparatus according to any one of claims 1 to 6.

8. the longitudinal axis of the medicament cylindrical container and a horizontal axis perpendicular to the longitudinal axis define a horizontal plane, and the center line of the camera intersects the horizontal plane at an angle of between 0° and 30°, preferably between 0° and 20°, more preferably between 0° and 10°, and most preferably at an angle of about 0°; and / or the longitudinal axis of the medicament cylindrical container and a vertical axis perpendicular to the longitudinal axis define a vertical plane, the center line of the camera intersecting the vertical plane at an angle of between 60° and 90°, preferably between 70° and 90°, more preferably between 80° and 90°, and most preferably at an angle of about 90°; and / or a horizontal axis perpendicular to the longitudinal axis of the medicament cylindrical container and a vertical axis perpendicular to the longitudinal axis and intersecting the center of the cylindrical portion of the medicament cylindrical container define a transverse plane, and the centerline of the camera intersects the transverse plane at an angle of between 0° and 30°, preferably between 0° and 20°, more preferably between 0° and 10°, and most preferably at an angle of about 0°; 8. An apparatus according to any one of claims 1 to 7.

9. The light source is a top light.

9. An apparatus according to any one of claims 1 to 8.

10. the light emitted from the light-emitting unit is unpolarized; 10. Apparatus according to any one of claims 1 to 9.

11. Advantageously, a method for inspecting polymeric drug cylinders by using a device according to any one of claims 1 to 10, said method comprising the steps of: - illuminating the medication cylinder with a light emitting unit; - receiving light emitted by said medication cylinder by a light receiving unit to obtain an image of said medication cylinder; characterizing defects in and / or on the medication cylinder based on the acquired images; A method comprising:

12. The method comprises: - illuminating said medication cylinder with the same and / or another light-emitting unit; receiving, by the same or a different light receiving unit, preferably by a different light receiving unit, light scattered by and / or transmitted through said medicine cylinder, advantageously illuminated by the same light emitting unit, in order to obtain an image of said medicine cylinder; characterizing defects in and / or on the medication cylinder based on the acquired images; further comprising: The method of claim 11.

13. analyzing the image to detect slides in the polymer of the medication cylinder; and / or analyzing the images to optimize and / or control the process for manufacturing the medicament cylinder; and / or If said medicament cylinder exhibits a value of Y in the formula Y=A / B of about 1.0, preferably between 0.9 and 1.0, more preferably between 0.8 and 1.0, more preferably between 0.7 and 1.0, more preferably between 0.6 and 1.0, more preferably between 0.5 and 1.0, more preferably between 0.4 and 1.0, more preferably between 0.3 and 1.0, more preferably between 0.2 and 1.0, more preferably between 0.1 and 1.0, more preferably between 0.05 and 1.0, said medicament cylinder being excluded from further processing, A is the maximum length in cm of any slide in the cylindrical portion of the medication cylinder; B is the length in cm of the cylindrical portion of the medicament cylinder; and / or If said medicament cylinder exhibits a value of Z, in the formula Z=A / B, of about 1.0, preferably between 0.9 and 1.0, more preferably between 0.8 and 1.0, more preferably between 0.7 and 1.0, more preferably between 0.6 and 1.0, more preferably between 0.5 and 1.0, more preferably between 0.4 and 1.0, more preferably between 0.3 and 1.0, more preferably between 0.2 and 1.0, more preferably between 0.1 and 1.0, more preferably between 0.05 and 1.0, said medicament cylinder being excluded from further processing, A is the size of the slide in cm ２ is the area at B is the diameter, in cm, of the cylindrical portion of the drug cylindrical container. ２ is the area at 13. The method according to claim 11 or 12.

14. Advantageously, a bundle of polymeric drug cylinders inspected by a device according to any one of claims 1 to 10 and / or a method according to any one of claims 11 to 13, said bundle comprising 10 or more drug cylinders, said medicament cylinder exhibits a value Y of about 0.5 or less, preferably 0.4 or less, more preferably 0.3 or less, more preferably 0.2 or less, more preferably 0.1 or less, more preferably 0.05 or less, more preferably 0.01 or less, in the formula Y=A / B; A is the maximum length in cm of any slide in the cylindrical portion of the medication cylinder; B is the length of the cylindrical portion of the medication cylinder; and / or said medicament cylinder exhibits a value Z of about 0.5 or less, preferably 0.4 or less, more preferably 0.3 or less, more preferably 0.2 or less, more preferably 0.1 or less, more preferably 0.05 or less, more preferably 0.01 or less, in the formula Z=A / B; A is the area, in cm, of the slide in the cylindrical portion of the drug cylinder ２ is the area at B is the diameter, in cm, of the cylindrical portion of the drug cylindrical container. ２ is the area at A bundle of polymeric drug cylinders.

15. The polymeric drug cylinder is a drug cylinder made of cyclic olefin copolymer (COC) or cyclic olefin polymer (COP), more preferably made of cyclic olefin copolymer (COC); The bundle of claim 14.

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