Detection and Characterization of Defects in Pharmaceutical Cylindrical Containers

Abstract

To provide a specific device and corresponding method for inspecting pharmaceutical cylindrical containers.SOLUTION: A specific bundle of pharmaceutical cylindrical containers is used.SELECTED DRAWING: Figure 1

Description

Technical Field

[0001] The present invention relates to a specific device for inspecting a pharmaceutical cylindrical container made of glass or polymer, the device including a support device, a light receiving unit, and a light emitting unit.

[0002] Furthermore, the present invention relates to a specific method for inspecting a pharmaceutical cylindrical container made of glass or polymer. Further, the present application describes a specific bundle of pharmaceutical cylindrical containers inspected by this specific device and / or this specific method corresponding to the present invention.

Background Art

[0003] In order to obtain a pharmaceutical cylindrical container with high quality, measurements need to be performed multiple times. For example, it is possible to improve the manufacturing process of the cylinder. However, these improvements have certain limitations, and the cost exceeds the resulting profit. Furthermore, there are certain quality levels that not all cylinders can surely achieve. Generally, it is possible to pack the manufactured cylinders into bundles without any inspection. Even if the overall average quality is high, this has the drawback that if one of the pharmaceutical cylinders has low quality, this will only become apparent at a later stage of manufacturing or even later.

[0004] Another approach to improving the overall quality of the cylinder is to manufacture cylinders with average quality and select out cylinders with quality below a specific value to improve the overall quality. Thereby, it is important to evaluate the entire cylinder in order to obtain a good evaluation of the cylinder. In order to manage the evaluation on the production line, a quick, efficient, and reliable evaluation is required. Thereby, a quick, efficient, and reliable evaluation of the cylinder is only possible when the cylinder is rotated about its axis. When a defect is detected, this pharmaceutical cylindrical container can be excluded from subsequent processing.

[0005] In particular, pharmaceutical cylindrical containers such as syringes, cartridges, vials, etc. must meet strict quality standards. For example, it must be avoided that these containers contain defects such as bubbles inside the material or particles on the surface. Since many of the pharmaceutical cylindrical containers related to the present invention are mass-produced, the inspection should be carried out as quickly as possible. Nevertheless, it must be ensured that pharmaceutical cylindrical containers containing any defects can be reliably identified and characterized and excluded from subsequent processing. For this purpose, it is important that defects can be reliably detected and characterized while the pharmaceutical cylindrical container is rotating about its longitudinal axis.

Summary of the Invention

Problems to be Solved by the Invention

[0006] The problem with known methods and devices is that the time required to inspect pharmaceutical cylindrical containers is long, and in particular, the detection and characterization of small defects are not reliable. Furthermore, in particular, the characterization of defects is a difficult task to solve even if a large number of images are obtained.

[0007] The invention described in the present application addresses the problem of improving and further developing an apparatus and method for inspecting glass or polymer pharmaceutical cylindrical containers so that rapid and reliable inspection and defect characterization of the pharmaceutical cylindrical containers are performed.

Means for Solving the Problems

[0008] In one embodiment, the present invention provides an apparatus for inspecting a glass or polymer pharmaceutical cylindrical container, the apparatus including a support device, a light emitting unit, and a light receiving unit. The support device supports the pharmaceutical cylindrical container such that the pharmaceutical cylindrical container is rotatable about its longitudinal axis. The light emitting unit includes a light source and is configured to illuminate the pharmaceutical cylindrical container with an inspection beam, and the light receiving unit includes a camera and is configured to receive a detection beam from the pharmaceutical cylindrical container and to acquire polarization information of the detection beam.

[0009] In another embodiment, the present invention advantageously provides a method for inspecting a glass or polymer pharmaceutical cylindrical container using the apparatus according to any one of claims 1 to 11, the method comprising: · illuminating the pharmaceutical cylindrical container with an inspection beam; · receiving at least one detection beam from the pharmaceutical cylindrical container by a light receiving unit; · acquiring polarization information of the detection beam and including.

[0010] In another embodiment, the present invention advantageously relates to a bundle of glass or polymer pharmaceutical cylindrical containers inspected by the apparatus according to any one of claims 1 to 11 and / or the method according to claim 12 or 13, the bundle including 10 or more pharmaceutical cylindrical containers, each pharmaceutical cylindrical container having a size of 40 mm or more, advantageously 30 mm or more, more advantageously 20 mm or more, more advantageously 10 mm or more, more advantageously 2 mm or more, presenting no defects on the outer surface, and / or each pharmaceutical cylindrical container having a size of 0.5 mm or more, advantageously 0.3 mm or more, advantageously 0.1 mm or more, more advantageously 0.05 mm or more, presenting no defects penetrating the wall portion.

[0011] By receiving a detection beam from a pharmaceutical cylindrical container and acquiring polarization information of the detection beam, it becomes possible to detect a defect in the pharmaceutical cylindrical container or a defect on the side surface of the pharmaceutical cylindrical container. Therefore, at least two different actions can be used to detect and characterize defects within or on the pharmaceutical cylindrical container.

[0012] For example, when an inspection beam of unpolarized light is reflected by the surface of a pharmaceutical cylindrical container, the reflected light beam is linearly polarized. This is especially the case when illumination and detection are performed at the Brewster angle. As a result, by measuring the linearly polarized detection beam, defects on the surface of the pharmaceutical cylindrical container appear darker compared to a defect-free surface. In contrast, when linearly polarized light is blocked by a filter, the scattered light generated by defects on the surface of the container appears brighter compared to the defect-free surface of the pharmaceutical cylindrical container.

[0013] Furthermore, by illuminating the pharmaceutical cylindrical container in a bright-field configuration and using linearly polarized light as the inspection beam, when the pharmaceutical cylindrical container is anisotropic, for example, when the pharmaceutical cylindrical container is manufactured from a polymer using injection molding, the plane of polarization will change. As a result, when polarization information of the detection beam is acquired, defects in the material of the pharmaceutical cylindrical container can be detected. Thereby, in particular, defects such as scratches, matte surfaces, or flow marks can be detected even when they are extremely small. Furthermore, defects within the material cause structural inhomogeneities such as stress. Using such an effect, it is possible to detect defects based on the inhomogeneity of the material around the defect. Therefore, it is further possible to characterize these defects. Therefore, a further advantage of the present invention is that the aspect of defects in a polymer-made pharmaceutical cylindrical container manufactured by injection molding is emphasized.

[0014] This is achieved by using the effect that an inspection beam of unpolarized light is polarized when it interacts with the polymer of the pharmaceutical cylindrical container, i.e., the electric field of the polymer. If the pharmaceutical cylindrical container contains some structural defect, such as a bubble, the above-mentioned polarization will not occur, or at least will not occur completely. Therefore, by obtaining information regarding the polarization of the light interacting with the glass or polymer pharmaceutical cylindrical container, i.e., the "polarization information", of the detection beam, defects in the pharmaceutical cylindrical container can be detected. Therefore, structural defects in polymer pharmaceutical cylindrical containers can be detected quickly and reliably by a device with a simple structure. A further advantage is that non-structural defects such as other impurities on the surface of the pharmaceutical cylindrical container do not cause a change in the electric field of the polymer, and structural defects are distinguished from other defects.

[0015] The term "pharmaceutical cylindrical container" refers, particularly in the claims and advantageously in the specification, to a cylindrical container that can be used to store pharmaceutical products, such as injection solutions or tablets. The pharmaceutical cylindrical container can be any special article of syringe, vial, ampoule, cartridge or tubing material. The diameter of the pharmaceutical cylindrical container 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 at least one pharmaceutical cylindrical container.

[0016] The term "longitudinal axis" refers, particularly in the claims and advantageously in the specification, to a line passing from the bottom to the top of the pharmaceutical cylindrical container, particularly the axis of rotation. The diameter of the pharmaceutical cylindrical container to be measured may be specified by a support device. This support device supports the pharmaceutical cylindrical container on its side when the pharmaceutical cylindrical container is not present within the device. For example, the support device presents three wheels that surround and support the pharmaceutical cylindrical container, and the diameter of the pharmaceutical cylindrical container to be measured is defined by the spacing between these three wheels when these three wheels are arranged at the inspection position.

[0017] In the present application, a "drug cylindrical container" includes at least a cylindrical portion. Thus, for example, a drug cylindrical container such as a syringe, a cartridge or an ampoule that includes a non-cylindrical end portion is a drug cylindrical container. Further, the side surface of the drug cylindrical container need not be smooth. The side surface may include grooves or ridges or corrugated portions or any other structure. Further, the side surface may have a wavy shape or any other shape as long as the drug cylindrical container presents a longitudinal axis. The container is made of glass, such as borosilicate glass or aluminosilicate glass, or a polymer such as cyclic olefin copolymer (COC) or cyclic olefin polymer (COP). Advantageously, the container is made of borosilicate glass, cyclic olefin copolymer (COC) or cyclic olefin polymer (COP). Most advantageously, the container is made of cyclic olefin copolymer (COC). It should be noted that at least one drug cylindrical container may be part of the device according to claim 1, and / or may be part of the method according to claim 12, and / or may be part of the bundle according to claim 14.

[0018] In the present application, a bundle is a unit for trading, loading, or packing for the distribution of pharmaceutical cylindrical containers. For example, usually, products of the same type are combined as a bundle when ordered together at a retail store or bundled in logistics. In the present invention, the pharmaceutical cylindrical containers of the bundle can be separated by a spacer, such as a plastic or paper sheet, or positioned in a holding device, such as a nest or a barrel, so that they do not contact each other during transportation. Not necessarily, but usually, the bundle is at least partially covered by a plastic thin film. Advantageously, one bundle is covered by a plastic thin film, and more advantageously, the bundle is covered by a plastic thin film and all the pharmaceutical cylindrical containers are sterilized, for example, by steam sterilization or gamma rays. For economic reasons, the distance between two cylinders in the bundle is advantageously less than 5 mm, more advantageously less than 3 mm, more advantageously less than 1 mm, more advantageously less than 0.5 mm, and most advantageously, the cylinders are in direct contact with each other to further reduce the size and weight of the bundle. The bundle usually contains more than 10, advantageously 10 to 1000, more advantageously 20 to 500, and most advantageously 40 to 250 pharmaceutical cylindrical containers. An example of a bundle is the iQ (trademark) platform of SCHOTT AG, that is, the immediately available platforms cartriQ (trademark), adaptiQ (registered trademark) or syriQ (registered trademark) of SCHOTT AG. One or more, advantageously 10 to 50, bundles can be stacked on a pallet or packed in another box for transportation.

[0019] The term "polarized light" refers to a light ray that includes linearly polarized light, circularly polarized light, or elliptically polarized light that can be detected by known methods and / or devices, having a wavelength in the range of preferably 1 nm to 100 μm, more preferably 10 nm to 10 μm, and most preferably 400 nm to 800 nm, especially in the claims and preferably in the specification.

[0020] The term "unpolarized light" refers to a light ray that does not include linearly polarized, circularly polarized, or elliptically polarized light that can be detected by known methods and / or devices, having a wavelength in the range of preferably 1 nm to 100 μm, more preferably 10 nm to 10 μm, and most preferably 400 nm to 800 nm, particularly in the claims and advantageously in the specification.

[0021] The term "polymer" refers to any kind of polymer, preferably in the claims and advantageously in the specification, a polymer containing molecules arranged in a long, at least essentially parallel structure, for example, a cyclic olefin copolymer (COC). Such a long, essentially parallel structure appears, for example, when a pharmaceutical cylindrical container is manufactured by injection molding.

[0022] Obtaining polarization information of the detection beam is, for example, obtaining an image in which only light having a specific orientation, for example, linearly polarized light, is considered, or all light except linearly polarized light is considered.

[0023] The expression "obtaining information of the detection beam other than the polarization of the detection beam" in the present application refers to, for example, an action of obtaining information on the wavelength and intensity of the detection beam and / or an action of collecting all light regardless of polarization, preferably obtaining information on the wavelength and intensity of the detection beam.

[0024] In the present application, the size of a defect refers to the longest dimension visible on the observation plane, that is, along the perpendicular to the outer surface of the pharmaceutical cylindrical container. It is consciously accepted that a three-dimensional defect may be longer.

[0025] Device The present invention relates to an apparatus for inspecting a glass or polymer pharmaceutical cylindrical container, the apparatus including a support device, a light emitting unit, and a light receiving unit. The support device supports the pharmaceutical cylindrical container such that the pharmaceutical cylindrical container is rotatable about its longitudinal axis. The light emitting unit includes a light source and is configured to illuminate the pharmaceutical cylindrical container with an inspection beam, and the light receiving unit includes a camera and is configured to receive a detection beam from the pharmaceutical cylindrical container and to acquire polarization information of the detection beam.

[0026] Support device In the present invention, the apparatus includes a support device, where the support device supports the pharmaceutical cylindrical container such that the pharmaceutical cylindrical container is rotatable about its longitudinal axis.

[0027] The support device can support the pharmaceutical cylindrical container on its side surface and / or at the top or bottom of the pharmaceutical cylindrical container.

[0028] Advantageously, the support device supports the drug cylindrical container on its side and includes at least two support wheels and one friction wheel, where the friction wheel is arranged such that the drug cylindrical container placed on the support wheels can rotate about its longitudinal axis by the friction wheel. Advantageous support devices are described in European Patent Application 19200246.7 and European Patent Application 19200221.0, which are incorporated herein by reference. In the present application, the side surface of the drug cylindrical container is the outer surface of the cylindrical portion of the drug cylindrical container. Advantageously, the device is not in direct contact with the bottom and top of the drug cylindrical container at all. During inspection, by placing the drug cylindrical container horizontally on the support wheels with its side, light can reach at least substantially the entire drug cylindrical container. Thus, if the drug cylindrical container is held only on its side by the holding means and the friction wheel during measurement, the drug cylindrical container can be inspected with at least substantially no shadow. If the drug cylindrical container is held only on its side by the holding means and the friction wheel during measurement, it is also possible to inspect the top and / or bottom of the drug cylindrical container.

[0029] Light emitting unit In the present invention, the device includes a light-emitting unit, the light-emitting unit includes a light source, and is configured to illuminate the drug cylindrical container with an inspection beam.

[0030] In an advantageous embodiment, the light source is a gas discharge lamp, a light-emitting diode or a laser, advantageously a light-emitting diode or a laser and / or an ultraviolet light source, advantageously a light-emitting diode or a laser and an ultraviolet light source, or a visible light source. Using an ultraviolet light source together with a visible light source has the advantage that two different inspection beams are provided such that two detection beams can be acquired simultaneously. By analyzing the two detection beams simultaneously, the inspection of the drug cylindrical container can be performed in an extremely short time.

[0031] Generally, the light emitting unit can emit polarized light and unpolarized light. Advantageously, the light emitting unit emits unpolarized light. More advantageously, the light emitting unit includes at least one light source that emits unpolarized light. Thus, an inspection beam can be easily generated.

[0032] In an advantageous embodiment, the light emitting unit includes at least one light source that emits polarized light and at least one depolarizer disposed between the light source and the drug cylindrical container. This has the advantage that a light source that emits polarized light can be arranged at a location where the inspection beam will be depolarized by the depolarizer. In an advantageous embodiment, the device includes a further light emitting unit. For example, the device includes one light emitting unit that emits linearly polarized light and a further light emitting unit that emits unpolarized light.

[0033] Filter / (de) polarizer / wave plate Generally, additional filters, (de)polarizers or wave plates are not required. However, if the device includes a filter or (de)polarizer, the light emitting unit or the light receiving unit can be used more easily and inexpensively, and furthermore, the information of the acquired polarization information becomes more accurate.

[0034] Thus, advantageously, the light emitting unit i) includes a polarizer, advantageously here the polarizer is a polarizer that polarizes by Fresnel reflection or a birefringent polarizer or a thin film polarizer or a wire grid polarizer, or ii) includes a depolarizer, advantageously here the depolarizer is a Cornu depolarizer or a Lyot type depolarizer or a wedge depolarizer or a time-varying depolarizer, where the polarizer or depolarizer is disposed between the light source and the drug cylindrical container, and / or iii) It includes a wavelength plate, and advantageously here the wavelength plate is a half-wave plate, a quarter-wave plate, a one-wave plate or a sensitive color plate, and here the wavelength plate is arranged between the drug cylindrical container and the light source.

[0035] Advantageously, the light receiving unit iv) It includes a polarizer, and advantageously here the polarizer is a polarizer that polarizes by Fresnel reflection, a birefringent polarizer, a thin film polarizer or a wire grid polarizer, and / or v) It includes a wavelength plate, and advantageously here the wavelength plate is a half-wave plate, a quarter-wave plate, a one-wave plate or a sensitive color plate. Here, the polarizer and / or the wavelength plate are arranged between the drug cylindrical container and the camera, and advantageously the wavelength plate is arranged between the drug cylindrical container and the polarizer.

[0036] More advantageously, the device includes the above-mentioned i and iii, or ii and iii, or i and iv, or i and v, or ii and iv, or ii and v, or i, iii and iv, or ii, iii and iv, or i, iii and v, or ii, iii and v, or ii, iii, iv and v.

[0037] Arranging the polarizer between the drug cylindrical container and the camera has the advantage that the polarization information of the detection beam can be obtained by an easy means. This is because only light of a specific polarization can pass through the polarizer, and light rays of other polarizations and / or unpolarized light rays are blocked.

[0038] The wavelength plate is preferably arranged between the drug cylindrical container and the light source, or between the drug cylindrical container and the camera of the light receiving unit. When the wavelength plate is arranged between the drug cylindrical container and the light source, preferably the wavelength plate is arranged between the drug cylindrical container and the polarizer or depolarizer. Preferably the wavelength plate is arranged between the drug cylindrical container and the light receiving unit, more preferably the quarter-wave plate is arranged between the drug cylindrical container and the light receiving unit, and more preferably the quarter-wave plate is arranged between the drug cylindrical container and the polarizer.

[0039] Advantageously, the device includes one or more interference filters, where this interference filter is arranged between the drug cylindrical container and the light source, or between the drug cylindrical container and the camera. Advantageously, the interference filter is a cut-off filter that cuts off light having a wavelength below or above 400 nm, preferably below. By using this type of filter, various light sources can be used and the manufacturing cost of the device can be reduced. Advantageously, the device includes an interference filter, where this interference filter is arranged between the drug cylindrical container and the light source, and where this interference filter is a cut-off filter that cuts off light having a wavelength below or above 400 nm, preferably below.

[0040] Light receiving unit In the present invention, the device includes a light receiving unit, the light receiving unit includes a camera, and is configured to receive a detection beam from the drug cylindrical container and to acquire polarization information of the detection beam.

[0041] Advantageously, the light receiving unit further includes an additional camera. Advantageously, the center line of the camera does not intersect a support device, for example, the wheel of the support device. More advantageously, the center line of the camera does not intersect any of them before this center line reaches the drug cylindrical container. Advantageously, at least one camera acquires an image of at least the entire cylindrical portion of the drug cylindrical container.

[0042] The total number of cameras is not particularly limited. The total number of cameras is related to the size of the drug cylindrical container. When more cameras are used, more images can be obtained within one time interval. For this reason, each light-receiving unit preferably includes two or more cameras, more preferably three or more cameras, more preferably five or more cameras, and most preferably ten or more cameras. However, if the number of cameras included in the light-receiving unit is too large, this interval for each camera with respect to the drug cylindrical container will increase significantly. Therefore, the light-receiving unit preferably includes 25 or fewer cameras, more preferably 20 or fewer cameras, more preferably 15 or fewer cameras, more preferably 10 or fewer cameras, and most preferably 5 or fewer cameras. Preferably, the light-receiving unit includes 8 to 18 cameras. This is because the entire drug cylindrical container can be inspected, and the light-receiving unit does not require so much space. A light-receiving unit including 11 to 14 cameras is extremely advantageous. This is because the space required for the light-receiving unit is minimized while still enabling good inspection of the entire drug cylindrical container.

[0043] Furthermore, the light-receiving unit preferably includes one camera, and this camera · obtains an image of the bottom of the drug cylindrical container and / or · obtains an overview image of the entire drug cylindrical container and / or · obtains an image of the sealing surface of the drug cylindrical container and / or · obtains an image of the shoulder of the drug cylindrical container and / or · obtains an image of the inside of the opening of the drug cylindrical container and / or · obtains an image of the outside of the opening of the drug cylindrical container and / or · obtains an image of the neck portion of the drug cylindrical container .

[0044] The pixel size, the sensor size, and the total number of pixels of the camera are not particularly limited. However, if the pixel size, the sensor size, and the number of pixels are excessively small, image noise increases and the sharpness of the image decreases. If the sensor size is excessively large, the cost for the camera increases excessively, and the increase in the size of the camera also makes it difficult to install it / them in the device. Furthermore, the larger the camera, the more difficult it becomes to arrange the camera around the container. For this reason, advantageously one or more cameras, preferably all cameras, exhibit the following characteristics. i) The pixel size is 3 μm * 3 μm or more and 15 μm * 15 μm or less, preferably 4 μm * 4 μm or more and 10 μm * 10 μm or less, more preferably 5 μm * 5 μm or more and 7 μm * 7 μm or less. ii) The sensor size is 3 mm * 5 mm or more and 15 * 20 mm or less, preferably 4 mm * 7 mm or more and 10 * 15 mm or less, more preferably 5 mm * 8 mm or more and 9 * 12 mm or less, and / or iii) The number of pixels is 1.5 megapixels or more and 5.0 megapixels or less, preferably 1.8 megapixels or more and 3.5 megapixels or less, more preferably 2.0 megapixels or more and 3.0 megapixels or less.

[0045] More preferably, the camera exhibits the above-described characteristics i, ii, iii, i + ii, i + iii, or ii + iii. More preferably, the camera exhibits the above-described characteristic i + ii + iii. Most preferably, all cameras of the light-receiving unit are the same camera and exhibit the above-described characteristic i + ii + iii.

[0046] The distance between the camera and the drug cylindrical container is not particularly limited. However, if this distance is excessively long, the quality of the image will deteriorate and the need for cameras will increase. If this distance is excessively small, it is impossible to arrange many cameras. Therefore, advantageously, the distance between the camera and the support device is advantageously 50 mm or more and 600 mm or less, more advantageously 80 mm to 450 mm, and even more advantageously 100 mm to 350 mm. Even more advantageously, the formula x = a / b holds, where a is the number of pixels of the camera, b is the distance between the camera and the support device in millimeters, and x is 1 * 10 4 [mm -1 or more and 5 * 10 5 [mm -1 or less, advantageously 5 * 10 4 [mm -1 or more and 3 * 10 5 [mm -1 or less, more advantageously 1 * 10 5 [mm -1 or more and 2 * 10 5 [mm -1 or less. When x is within the above range, extremely small defects can also be detected.

[0047] In an advantageous embodiment, the light receiving unit is configured to measure a first linearly polarized light beam and a second linearly polarized light beam, and the polarization plane of the first linearly polarized light beam and the polarization plane of the second linearly polarized light beam intersect at an angle of 10° to 170°, advantageously at an angle of 45° or 90°, and more advantageously at an angle of 90°.

[0048] In an advantageous embodiment, the camera is a polarization camera. By providing a polarization camera, information regarding the polarization of the detection beam can be obtained extremely easily. Examples of polarization cameras are cameras having the polarization image sensors IMX250MZR (black and white) or IMX250MYR (color) of Sony Corporation.

[0049] In an advantageous embodiment, the light receiving unit is configured to receive the detection beam from the pharmaceutical cylindrical container and is further configured to obtain information on the detection beam other than the polarization of the light. By obtaining two images, namely one image independent of the polarization of the light and one image with the polarization information of the detection beam, defects can be detected and characterized quickly and more reliably. For example, when the light receiving unit obtains a first image of the detection beam reflected from the pharmaceutical cylindrical container, the detection beam can be linearly polarized if the container does not contain defects. For example, if a filter / polarizer that blocks linearly polarized light is arranged between the pharmaceutical cylindrical container and the light receiving unit, defects penetrating the outer surface of the pharmaceutical container, such as defects on the outer surface and defects penetrating the wall, can be detected very accurately. When this first image is compared with a second image showing all defects, for example, a simple bright-field image obtained using a normal camera without using a filter, the light passes through the entire wall of the pharmaceutical cylindrical container, and the defects can be characterized very easily simply by comparing the two images, and no further effort is required. This increases the speed of defect characterization. Thus, advantageously, the apparatus includes a light emitting unit and a light receiving unit, which are configured to obtain a bright-field image independent of the polarization of the light, i.e., the second image. In other words, the light receiving unit can include at least one polarization camera for obtaining the first image and at least one conventional camera for obtaining the second image. Advantageously, the pharmaceutical cylindrical container is rotatable about its longitudinal axis to obtain an overall evaluation.

[0050] In an advantageous embodiment, the light receiving unit is configured to measure the intensity and / or wavelength of the detection beam. This has the advantage that further defects that result in a reduction in intensity can be detected. Advantageously, at least one camera is configured to measure the intensity and / or wavelength of the detection beam, and one camera is configured to receive the detection beam from the pharmaceutical cylindrical container and obtain the polarization information of the detection beam without measuring the intensity and / or wavelength of the detection beam.

[0051] Advantageously, the light receiving unit is configured to receive a detection beam from the drug cylindrical container and acquire polarization information of the detection beam, and i) configured to measure a first linearly polarized light beam and a second linearly polarized light beam, wherein the polarization plane of the first linearly polarized light beam and the polarization plane of the second linearly polarized light beam intersect at an angle of 10° to 170°, advantageously at an angle of 45° or 90°, more advantageously at an angle of 90°, and / or ii) configured to receive a detection beam from the drug cylindrical container and acquire information of the detection beam regardless of the polarization of light, and / or iii) configured to measure the intensity and / or wavelength of the detection beam.

[0052] More advantageously, the light receiving unit is configured according to i+ii or i+iii or ii+iii or i+ii+iii described above. The information may be obtained by one camera or by a plurality of cameras. Advantageously, all information of the detection beam is collected by 1 to 3 cameras, advantageously 1 to 2 cameras, more advantageously 1 camera. Those skilled in the art will understand that it is necessary to adapt the light receiving unit so that polarization information of two detection beams including different wavelengths can be acquired in particular. Furthermore, those skilled in the art will understand that it is necessary to adapt the light receiving unit so that all necessary polarization information can be acquired.

[0053] Arrangement The arrangement of the light emitting unit and / or the light receiving unit is not particularly limited as long as the light receiving unit can receive the detection beam from the drug cylindrical container and acquire the polarization information of the detection beam.

[0054] In an advantageous embodiment, the light emitting unit and / or the light receiving unit, preferably the light emitting unit and the light receiving unit, are arranged such that the light reflected by the pharmaceutical cylindrical container defines the detection beam. This has the advantage that the detection beam has a relatively high intensity. Alternatively or additionally, the light emitting unit and / or the light receiving unit, preferably the light emitting unit and the light receiving unit, are arranged such that the light passing through the pharmaceutical cylindrical container defines the detection beam. The advantage of using the passed light is that the two side walls of the container can be inspected simultaneously. It should be noted that the reflected light can be selected as the first detection beam and the passed light can be selected as the second detection beam. By analyzing the polarization of the first detection beam and the second detection beam, extremely small defects such as bubbles can be detected.

[0055] Advantageously, the device includes a pharmaceutical cylindrical container, and the light emitting unit and / or the light receiving unit are arranged such that the formula α = β = arctan(n) is satisfied, where α is the angle between the center line of the light source and the perpendicular N to the surface of the pharmaceutical cylindrical container, β is the angle between the center line of the camera and the perpendicular N to the surface of the pharmaceutical cylindrical container, and n is the refractive index of the glass or polymer of the pharmaceutical cylindrical container.

[0056] In an advantageous embodiment, the light is radiated onto the pharmaceutical cylindrical container such that the detection beam intersects the center line of the camera at an angle in the range of 0° to 30°, preferably 0° to 15°. Thus, the intensity of the detection beam increases.

[0057] Control unit In an advantageous embodiment, the device includes a support device, in particular a friction wheel of the support device, a light-emitting unit, and a control unit that controls the light-receiving unit. By providing the control unit, visualization of the entire pharmaceutical cylindrical container is achieved at a high pace, and the light-receiving unit and / or the light-emitting unit and / or the activation / deactivation of the friction wheel can be controlled so that the largest part of the pharmaceutical cylindrical container can be inspected in the shortest time. Advantageously, the control unit is configured to measure one pharmaceutical cylindrical container in 0.3 seconds to 10 seconds, more advantageously 0.5 seconds to 8 seconds, and even more advantageously about 1 second. Such a short measurement time can be achieved by the device of the present invention by excellent adjustment of the mutual angle between the light source and the camera and a specific type of continuous measurement (see below).

[0058] In an advantageous embodiment, the control unit is configured to rotate the cylindrical body 360° about its longitudinal axis. Accordingly, the light-receiving unit can acquire an image of the entire pharmaceutical cylindrical container and detect defects regardless of their positions on or within the material of the pharmaceutical cylindrical container.

[0059] In another embodiment, the control unit is configured to rotate the cylindrical body with an increment between 0.5° and 4°, advantageously between 0.5° and 3.5°, more advantageously between 1° and 3°, and most advantageously 2°. Rotating the pharmaceutical cylindrical container with the above-mentioned increment is advantageous because sufficient images can be acquired to create a virtual 3D image of the pharmaceutical cylindrical container and the camera has sufficient time to take images using different illuminations at the same position. Based on this 3D image, it can be determined whether the pharmaceutical cylindrical container meets the quality standards.

[0060] In an advantageous embodiment, the control unit is configured to rotate the cylindrical body between image acquisitions.

[0061] In an advantageous embodiment, the control unit is configured to adjust the activation / deactivation of each camera of the light receiving unit and the light emitting unit based on the speed of the friction wheel. With such a setting, the device can operate at any speed and can change the speed during the measurement of one pharmaceutical cylindrical container. This may be necessary to adjust the speed of the device to match the varying production speed.

[0062] In an advantageous embodiment, the control unit i) is configured to measure one pharmaceutical cylindrical container in 0.3 seconds to 10 seconds, more preferably 0.5 seconds to 8 seconds, and even more preferably about 1 second, ii) is configured to rotate the cylinder 360° about its longitudinal axis, iii) is configured to rotate the cylinder with an increment between 0.5° and 4°, preferably between 0.5° and 3.5°, more preferably between 1° and 3°, and most preferably 2°, iv) is configured to rotate the cylinder between image acquisitions, and / or v) is configured to adjust the activation / deactivation of each camera of the light receiving unit and each light emitting surface of the light emitting unit based on the speed of the friction wheel.

[0063] In another advantageous embodiment, the control unit is configured to meet the above-described characteristics, i, ii, iii, iv, v, i + ii, i + iii, i + iv, i + v, ii + iii, ii + iv, ii + v, iii + iv, iii + v, iv + v, i + ii + iii, i + ii + iv, i + ii + v, i + iii + iv, i + iii + v, i + iv + v, ii + iii + iv, ii + iii + v, ii + iv + v, iii + iv + v, i + ii + iii + iv, i + ii + iii + v, i + ii + iv + v, i + iii + iv + v or i + ii + iii + iv + v.

[0064] After obtaining images at all positions of the rotating pharmaceutical cylindrical container, the computer combines all the images in order to obtain a 3D image of the pharmaceutical cylindrical container. In this 3D image, it is possible to distinguish different types of defects, and it is also possible to specify the position and orientation of the defects. This is made possible by the specific arrangement of the cameras and light sources around the pharmaceutical cylindrical container as described above. When the device includes a plurality of cameras and / or a plurality of light sources as described above, a complete image of the pharmaceutical cylindrical container, including the non-cylindrical end portions of the pharmaceutical cylindrical container, can be obtained. The minimum size of the defects detectable by the above-described device is related to the distance between the cameras, the total number of pixels, the sensor size, etc. The cameras of the present invention can accurately detect defects having a size of 16 μm or more.

[0065] Control device In another advantageous embodiment, the device includes a control device, which is configured to exclude the pharmaceutical cylindrical container from subsequent processing when a defect on the outer surface having a size of 40 mm or more and / or a defect penetrating the wall portion having a size of 0.5 mm or more, preferably 0.3 mm or more, preferably 0.1 mm or more, more preferably 0.05 mm or more is detected in the pharmaceutical cylindrical container. The control device is preferably included within a control unit.

[0066] Another embodiment provides a device for inspecting a pharmaceutical cylindrical container made of glass or polymer, and the device is configured such that the pharmaceutical cylindrical container is inspected in 1 second or less, preferably 0.9 second or less, preferably 0.8 second or less, more preferably 0.6 to 0.9 seconds, preferably 0.7 to 0.8 seconds, and / or the device is configured such that defects on the outer surface having a size of 40 mm or more, preferably 30 mm or more, more preferably 20 mm or more, more preferably 10 mm or more, more preferably 2 mm or more can be detected, and / or This device is configured to be able to detect defects penetrating the wall portion, having a size of 0.5 mm or more, preferably 0.3 mm or more, preferably 0.1 mm or more, more preferably 0.05 mm or more.

[0067] Method The present invention preferably relates to a method for inspecting a pharmaceutical cylindrical container made of glass or polymer, using the device according to any one of claims 1 to 11, and this method comprises: · illuminating the pharmaceutical cylindrical container with an inspection beam; · receiving at least one detection beam from the pharmaceutical cylindrical container by a light receiving unit; · obtaining polarization information of the detection beam and includes.

[0068] In an advantageous embodiment, when a defect on the outer surface having a size of 40 mm or more, preferably 30 mm or more, more preferably 20 mm or more, more preferably 10 mm or more, more preferably 2 mm or more, and / or a defect penetrating the wall portion having a size of 0.5 mm or more, preferably 0.3 mm or more, preferably 0.1 mm or more, more preferably 0.05 mm or more is identified by analyzing at least one acquired image of the pharmaceutical cylindrical container, the pharmaceutical cylindrical container is excluded from subsequent processing. This has the advantage that high quality standards for pharmaceutical cylindrical containers, such as those defined for pharmaceutical cylindrical containers such as syringes, cartridges or ampoules, are met.

[0069] In an advantageous embodiment of the described method, if the inspection beam is not at least partially polarized, the pharmaceutical cylindrical container is excluded from subsequent processing.

[0070] Bundle Furthermore, the present invention relates to a bundle of pharmaceutical cylindrical containers made of glass or polymer, where the bundle comprises 10 or more pharmaceutical cylindrical containers, each pharmaceutical cylindrical container having a size of 40 mm or more, presenting no defects on the outer surface, and / or preferably and each pharmaceutical cylindrical container has no defects penetrating the wall portion, having a size of 0.5 mm or more, preferably 0.3 mm or more, preferably 0.1 mm or more, and more preferably 0.05 mm or more.

[0071] The bundle having the above-mentioned exceptional quality is obtained by inspecting the bundle by means of an apparatus corresponding to an embodiment of the present invention and / or a method corresponding to an embodiment of the present invention. Thus, preferably, the pharmaceutical cylindrical containers are inspected by means of an apparatus corresponding to an embodiment of the present invention and / or a method corresponding to an embodiment of the present invention.

[0072] There are several ways to advantageously design and further develop the teachings of the present invention. For this purpose, on the one hand, reference should be made to the claims dependent on claims 1, 12 and 14, and on the other hand, reference should be made to the description following the advantageous examples of the illustrated embodiments of the present invention. In connection with the description of the advantageous embodiments of the present invention using the figures, generally advantageous embodiments and further developments of the teachings are described in FIGS. 1 to 7.

Brief Description of the Drawings

[0073]

Figure 1

Figure 2

Figure 3

Figure 4

Figure 5

Figure 6

Figure 7

[0074] In the following description of the embodiments, the same reference numerals refer to similar components.

[0075] In FIG. 1, the apparatus includes a light emitting unit 7 and a light receiving unit 8. The light emitting unit 7 includes a light source 9 for illuminating the pharmaceutical cylindrical container 1 with an inspection beam 10. The inspection beam 10 may not contain polarization. Due to reflection at the surface, the detection beam 11 will be polarized if the container 1 does not contain defects. Thus, the light receiving unit 8 acquires polarization information of the detection beam 11 to detect defects, such as air bubbles, on the outer surface of the pharmaceutical cylindrical container 1. In this embodiment, the light receiving unit 8 can include a polarization camera 12 to acquire polarization information of the detection beam 11. The arrangement of the light source and the camera is made such that illumination and detection are performed at the Brewster angle. The pharmaceutical cylindrical container 1 is rotatable 360° during measurement.

[0076] The apparatus shown in FIG. 2 includes a light emitting unit 7 and a light receiving unit 8. The light receiving unit 8 includes a camera 13 and a polarizer 14. The polarizer 14 is used to acquire information regarding the polarization of the detection beam 11. This is because only light of a specific polarization can pass through the polarizer 14. Thus, if the pharmaceutical cylindrical container 1 contains defects, the detection beam 11 is not polarized and the polarizer 14 blocks the non-polarized detection beam 11. Since the light does not (substantially) reach the camera 13, the camera 13 will not (substantially) detect light. Further features of the apparatus shown in FIG. 2 correspond to those of the apparatus shown in FIG. 1.

[0077] The device in FIG. 3 includes a light emitting unit 7 and a light receiving unit 8. In this embodiment, the light passing through the drug cylindrical container 1 defines a detection beam 11. Further, the device shown in FIG. 3 corresponds to the embodiment shown in FIG. 1.

[0078] FIG. 4 shows an embodiment of a device for inspecting the drug cylindrical container 1. As already described in connection with FIG. 2, the light receiving unit 8 includes a camera 13 and a polarizer 14, whereby the light passing through the drug cylindrical container 1 defines a detection beam 11.

[0079] FIG. 5 shows another embodiment of the device. In this embodiment, the light receiving unit 8 includes two polarization cameras 12, 12'. The first polarization camera 12 is used to detect a first detection beam 11 defined by the light reflected by the drug cylindrical container 1. The second polarization camera 12' is used to detect a second detection beam 11' defined by the light passing through the drug cylindrical container 1. Those skilled in the art will understand that at least one of the polarization cameras 12, 12' can be replaced by an arrangement including the optical sensor and the polarizer shown in FIGS. 2 and 4. Further, the device can include a polarization camera 12 and a camera 12' which is not a polarization camera but a conventional camera. By comparing the image obtained by the polarization camera with the image obtained by the conventional camera, defects can be detected very easily.

[0080] Figure 6 shows a schematic cross-sectional view of a pharmaceutical cylindrical container 1 made of a polymer by injection molding. Here, the pharmaceutical cylindrical container 1 contains a defect 6. In this embodiment, the defect 6 is typically a bubble that can occur after the injection molding process. Due to the defect 6, the arrangement of the molecules 2 has collapsed, and the electric field E of the pharmaceutical cylindrical container 1 has at least decreased. As can be seen, the incident light ray 3 is partially reflected, that is, a reflected light ray 4 is generated, and the incident light ray 3 partially passes through the pharmaceutical cylindrical container 1, that is, a transmitted light ray 5 is generated. If the incident light ray 3 contains linearly polarized light, the transmitted light ray 5 will have linearly polarized light. However, the plane of polarization has changed. Therefore, by acquiring the polarization information of the light ray 5, it is possible to detect defects 6 such as bubbles or any other type of defect that reduces or eliminates the electric field E of the pharmaceutical cylindrical container 1 made of glass or polymer.

[0081] Furthermore, in all the embodiments described in FIGS. 1 to 6, it should be noted that the light-emitting unit 7 may include several light sources, for example, two light sources, so that the pharmaceutical cylindrical container 1 can be advantageously illuminated with two inspection beams containing different wavelengths. These are, for example, a first detection beam defined by UV light and a second detection beam defined by visible light. Those skilled in the art will understand that the light-receiving unit 8 should be correspondingly adapted to acquire information regarding the polarization of at least two of these different detection beams.

[0082] Figure 7 shows a block diagram of an embodiment of this method. This method is used for inspecting a pharmaceutical cylindrical container made of glass or polymer. In a first step 15, the pharmaceutical cylindrical container is illuminated with an inspection beam, for example, unpolarized light. In a second step 16, at least one detection beam is received from the pharmaceutical cylindrical container by a light-receiving unit and analyzed regarding polarization. A further step 17 may be performed, for example, excluding the pharmaceutical cylindrical container from subsequent processing if the detection beam is at least partially unpolarized.

[0083] Those skilled in the art related to the present invention, having the benefit of the teachings presented in the foregoing description and the related drawings, will doubtless conceive of many modifications and other embodiments of the invention described herein. Accordingly, it is to be understood 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 Signs

[0084] 1 Pharmaceutical cylindrical container 2 Polymer molecule 3 Light ray (incident) 4 Light ray (reflected) 5 Light ray (passing through) 6 Defect 7 Light-emitting unit 8 Light-receiving unit 9 Light source 10 Inspection beam 11, 11’ Detection beam 12, 12’ Polarization camera 13 Camera 14 Polarizer 15 First step 16 Second step 17 Further step

Claims

1. An apparatus for inspecting a pharmaceutical cylindrical container made of glass or polymer, said apparatus comprising a support device, a light emitting unit, and a light receiving unit, said support device supporting the pharmaceutical cylindrical container such that the pharmaceutical cylindrical container is rotatable about its longitudinal axis, said light emitting unit comprising a light source and being configured to illuminate at least a part of the pharmaceutical cylindrical container with an inspection beam which is non-polarized light, said light receiving unit comprising a camera and being configured to receive a detection beam from the pharmaceutical cylindrical container and to acquire polarization information of the detection beam, said light emitting unit comprising a polarizer or a birefringent polarizer or a thin film polarizer or a wire grid polarizer for polarizing by Fresnel reflection, or said light emitting unit comprising a Cornu depolarizer or a Lyot type depolarizer or a wedge depolarizer or a time-varying depolarizer, and / or said light emitting unit comprising a half-wave plate, a quarter-wave plate, or a one-wave plate or a sensitive color plate, said wave plate being disposed between the pharmaceutical cylindrical container and the light source, apparatus.

2. said light source being a gas discharge lamp and / or a light emitting diode and / or a laser, The apparatus according to claim 1.

3. said light receiving unit comprising a polarizer or a birefringent polarizer or a thin film polarizer or a wire grid polarizer for polarizing by Fresnel reflection, and / or said light receiving unit comprising a half-wave plate, a quarter-wave plate, or a one-wave plate or a sensitive color plate, said polarizer and / or said wave plate being disposed between the pharmaceutical cylindrical container and the camera, said wave plate being disposed between the pharmaceutical cylindrical container and the polarizer, The apparatus according to claim 1 or 2.

4. said light receiving unit being configured to measure a first linearly polarized light beam and a second linearly polarized light beam, The apparatus according to any one of claims 1 to 3.

5. said camera being a polarization camera, The apparatus according to any one of claims 1 to 4.

6. The light receiving unit is configured to receive a detection beam from the drug cylindrical container, and further configured to acquire information of the detection beam other than the polarization of the detection beam. The apparatus according to any one of claims 1 to 5.

7. The light receiving unit is configured to measure the intensity and / or wavelength of the detection beam. The apparatus according to any one of claims 1 to 6.

8. The light emitting unit and / or the light receiving unit are arranged such that the light reflected by the drug cylindrical container defines the detection beam. The apparatus according to any one of claims 1 to 7.

9. The light emitting unit and / or the light receiving unit are arranged such that the light passing through the drug cylindrical container defines the detection beam. The apparatus according to any one of claims 1 to 8.

10. The apparatus includes a drug cylindrical container, and the light emitting unit and / or the light receiving unit are arranged such that the formula α = β = arctan(n) is satisfied, where α is the angle between the center line of the light source and the perpendicular N to the side surface of the drug cylindrical container, β is the angle between the center line of the camera and the perpendicular N to the side surface of the drug cylindrical container, and n is the refractive index of the glass or polymer of the drug cylindrical container. The apparatus according to any one of claims 1 to 9.

11. A method for inspecting a drug cylindrical container made of glass or polymer by using the apparatus according to any one of claims 1 to 10, the method comprising: - illuminating the drug cylindrical container with a detection beam; - receiving at least one detection beam from the drug cylindrical container by a light receiving unit; - acquiring polarization information of the detection beam. A method comprising the steps of.

12. When a defect on the outer surface having a size of 40 mm or more and / or a defect penetrating the wall portion having a size of 0.5 mm or more is identified by analyzing at least one acquired image of the drug cylindrical container, the drug cylindrical container is excluded from subsequent processing. The method according to claim 11.

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