System and method for optically detecting particles in transparent medical containers

Abstract

The invention relates to a method and a system for optically detecting particles in transparent medical containers, in particular film bags, which are filled with a medical liquid. The medical containers are moved on a transport device, in particular a conveyor belt, and comprise the steps of: illuminating a medical container to be inspected with a first light source, wherein the container is inspected at least in portions by means of a first camera system in front of a dark background; illuminating the medical container to be inspected with a second light source, wherein the container is inspected at least in portions by means of a second camera system against a light background; and transilluminating the medical container to be inspected using a third light source, wherein the container is inspected at least in portions by means of a third camera system.

Description

[0001] Fresenius Kabi Deutschland GmbH FK24117-08-PAT-WO

[0002] System and method for the optical detection of particles in transparent medical containers

[0003] Description

[0004] Field of invention

[0005] The invention relates to a system and a method for the optical detection of particles in medical containers. In particular, the invention relates to the automated detection of visible particles in the medical container.

[0006] Background of the invention

[0007] Medical containers can be designed as transparent containers, for example as foil bags. These are filled with an infusion solution and include at least one port to which a transfer set can be connected to transfer the medical fluid from the container into the patient.

[0008] During the manufacture of such medical containers, it can occasionally happen that particles large enough to be seen with the naked eye enter the medical fluid. Such particles can be caused, in particular, by the equipment and tools used, as well as by the workers involved in production. Often, it is a single particle in the medical fluid.

[0009] The introduction of such particles is rare and, due to the filter installed in the transfer set, generally does not pose any significant risks. Nevertheless, a visual inspection is recommended. Fresenius Kabi Deutschland GmbH FK24117-08-PAT-WO

[0010] This is often already required in the manufacture of such a medical device due to regulatory requirements.

[0011] In practice, the visual inspection of medical containers is usually carried out by visual inspection with the human eye. This is time-consuming, partly due to the redundancy that is usually required. Furthermore, manual visual inspection is very strenuous for the inspecting employee and can be prone to errors, partly due to the rare occurrence of such a particle in the medical fluid.

[0012] The patent application WO 2024 / 141672 Al describes an automated detection of particles in medical containers. This involves the use of a light source and an imaging camera. The image data is evaluated by an artificial intelligence (AI) with a neural network.

[0013] It has been shown that achieving sufficient reliability in particle detection using such an AI-based system is difficult. This could be due, among other things, to the fact that medical containers are usually marked with a label (e.g., product name, batch number, barcode). When using the system for medical containers with different labels, sufficient reliability can generally only be guaranteed if the AI ​​has also been trained on the different labels.

[0014] Object of the invention

[0015] In contrast, the invention is based on the objective of providing a method for the optical detection of particles in transparent medical containers and a system for Fresenius Kabi Deutschland GmbH FK24117-08-PAT-WO

[0016] To provide inspection of medical containers where reliability is improved compared to the state of the art and / or the effort required to train the AI ​​is reduced.

[0017] Summary of the invention

[0018] The object of the invention is already solved by a method for the optical detection of particles in transparent medical containers and by a system for the inspection of medical containers according to one of the independent claims and / or the independent embodiments.

[0019] Preferred embodiments and further developments of the invention can be found in the subject matter of the dependent claims, the description and the drawings.

[0020] The invention relates to a method for the optical detection of particles in transparent medical containers, in particular foil bags, filled with a medical liquid, wherein the medical containers are moved on a transport device, in particular a conveyor belt, comprising the steps:

[0021] Illuminating a medical container to be inspected with a first light source, wherein the container is inspected at least section by section using a first camera system against a dark background,

[0022] Illuminating the medical container to be inspected with a second light source, wherein the container is inspected at least section by section using a second camera system against a bright background,

[0023] X-raying the medical container to be inspected with a third light source, wherein the container is at least partially illuminated by means of a third camera system Fresenius Kabi Deutschland GmbH FK24117-08-PAT-WO

[0024] is being inspected.

[0025] According to the invention or this embodiment of the invention, the medical containers are inspected with three camera systems, wherein the medical container is inspected on a dark background during one inspection and on a light background during a second inspection.

[0026] The container is then inspected and X-rayed by a third camera system.

[0027] It has been found that this improves both the reliability of the detection and reduces the training effort for the optionally used artificial intelligence for particle detection.

[0028] Furthermore, the entire inspection can preferably be carried out while the containers are being moved on the transport equipment, in particular on the conveyor belt. Specifically, the containers do not need to be removed from the transport equipment used for production.

[0029] Preferably, the medical containers are inspected before being packed in a secondary packaging, e.g. a tear-off bag.

[0030] This type of inspection does not significantly interfere with the ongoing production process. Sources of error associated with manual optical inspection can be avoided or reduced.

[0031] The containers are designed specifically as foil bags with at least one port for dispensing the medical fluid. The medical fluid can be, for example, an infusion solution, such as a saline and / or glucose solution. Furthermore, Fresenius Kabi Deutschland GmbH FK24117-08-PAT-WO

[0032] It is a nutritional solution, in particular a parenteral nutritional solution. The medical fluid may, for example, contain an active ingredient.

[0033] The method according to the invention is preferably suitable for medical liquids that are so transparent that optical inspection for visible particles is possible.

[0034] The method is specifically designed to detect particles in the size range of 200 pm and larger, especially from 300 pm to 5 mm.

[0035] The containers can be designed, in particular, as foil bags made of welded polyolefin films. Specifically, the containers can be made of multi-layered, welded polypropylene-based films. Such films have high transparency and therefore allow for good optical detection by the process.

[0036] For example, an LED light source can be used as the first, second and / or third light source.

[0037] The first, second and / or third camera system preferably comprises a digital camera with a pixel-based image sensor. A color camera is preferably used.

[0038] Preferably, the first, second, and / or third camera system(s) take pictures of the medical container to be inspected while it is being moved by the transport device. It is understood that the frame rate of each camera must be high enough to ensure a sharp image is captured during the movement. Such cameras are available from Fresenius Kabi Deutschland GmbH FK24117-08-PAT-WO

[0039] Sufficient resolution and sufficient frame rate are available as industrial cameras.

[0040] Dark and light backgrounds as defined in the invention differ in that the lighter background has an L* value in the Lab color space that is higher than that of the dark background. The L* value of the dark background is preferably less than 40, more preferably less than 30. The L* value of the light background is preferably more than 60, more preferably more than 70, and most preferably more than 90.

[0041] The dark background is specifically black and the light background is white. The values ​​of a* and b* are preferably less than 30 for the light and dark backgrounds, particularly preferably less than 10, and most particularly less than 5.

[0042] Preferably, the light background and / or the dark background have a matte finish. In particular, the gloss level (according to DIN EN 13300, 2023-2) can be G3, preferably G4.

[0043] During the step of X-raying the medical container to be inspected, the container is not positioned on a contrasting or reflective background. The light from the third light source can pass through the container, at least partially, without being reflected or absorbed by a surface immediately adjacent to the container.

[0044] Preferably, the X-ray inspection is provided by ensuring that the walls of the container are at least partially visible in the camera's field of view. This can be achieved, in particular, by a gap between a first and a second conveyor belt. Fresenius Kabi Deutschland GmbH FK24117-08-PAT-WO

[0045] According to another embodiment, the container is gripped by a transport device, for example at the connector or at a weld seam, in order to then be able to X-ray the interior filled with medical fluid.

[0046] In another embodiment of the invention, the container is also arranged on a transparent base during the X-ray examination.

[0047] According to a preferred embodiment of the invention, the detection of particles in the medical containers to be inspected is carried out by means of automated detection by a computer system.

[0048] According to one embodiment of the invention, the first camera system, the second camera system and / or the third camera system comprises a computer system which automatically detects particles present in the container to be inspected.

[0049] The computer systems of the camera systems can also be combined into a single computer system, for example, a single computer.

[0050] Preferably, the computer system is equipped with an artificial intelligence that is trained with reference containers into which particles are introduced, and in particular also with reference containers without introduced particles.

[0051] Medical containers are provided to train the artificial intelligence, each containing at least one particle large enough to trigger the container's rejection. A large number of images of medical containers are fed into the system. (Fresenius Kabi Deutschland GmbH FK24117-08-PAT-WO)

[0052] in which at least one particle is present and in which no detectable particle is present.

[0053] During the training phase, the AI-based computer system is programmed with information on which containers should be sorted out due to at least one particle and which contain no particles.

[0054] By comparing the data with the image data, AI can now provide automated recognition.

[0055] According to one embodiment of the invention, the image data from the first, second, and third camera systems are evaluated independently of one another. In this embodiment, the container is checked for particles at the station formed by the three camera systems, independently of the other stations, so that it can be sorted out if necessary.

[0056] In another embodiment of the invention, the artificial intelligence is trained in such a way that it takes into account the image data from at least two, preferably all three, camera systems for the detection of a particle.

[0057] As explained above, it has been shown that by providing image data from three different camera systems according to the invention, a reduced training effort and an increased detection probability of the AI ​​can be achieved in particular. This applies especially when the image data of all three camera systems, relating to the respective container, are evaluated together by the AI.

[0058] Without being bound to theory, it is assumed that the three different camera systems enable, among other things, improved particle detection. SoFresenius Kabi Deutschland GmbH FK24117-08-PAT-WO

[0059] The particles can have different shapes and colors. Furthermore, some particles tend to float in the medical fluid, while others sink to the bottom or float on the surface during transport. Additionally, the three different camera systems appear to make it easier for the AI ​​to distinguish between a printed label on the container and a particle inside it.

[0060] Thus, as provided for in one embodiment of the invention, the method can also be used for containers that are printed with a design with which the AI ​​has not been trained.

[0061] According to a preferred embodiment of the invention, the container is inspected from at least two sides, in particular from above and from below. In particular, the viewing direction of one camera system, especially the third camera system, is directed downwards towards the container, while the viewing direction of another camera system, in particular the first and / or second camera system, is directed downwards towards the container.

[0062] Inspecting from below allows for better detection of particles that settle at the bottom.

[0063] In a further development of the invention, the color of the first, second and / or third light source, i.e. the color of the light emitted by the light source, is adapted to the color of the imprint on the medical container to be inspected.

[0064] This means that the a* and b* values ​​of the light field generated by the light source are adjusted to the color of the print. In particular, the a* value corresponds to Fresenius Kabi Deutschland GmbH FK24117-08-PAT-WO

[0065] and / or b* value that of the imprint + / - 20 , preferably + / -10 , particularly preferably + / - 5. In particular, a white light source is used for a black or white imprint.

[0066] A light field adapted to the color of the print can be provided, for example, via a color filter arranged in the beam path of the light source or via RGB LEDs.

[0067] White light for inspecting containers with black or white printing can be provided, for example, by RGB LEDs or LEDs with a conversion layer.

[0068] According to one embodiment of the invention, the dark background and / or the light background are each provided by the transport device, in particular the conveyor belt.

[0069] The conveyor belt can be colored dark or light, or have a dark or light coating.

[0070] This makes it easy to provide a dark or light background for the first and second camera systems without additional components.

[0071] In a preferred embodiment of the invention, the method is carried out such that, during the step of inspecting the container with the first and / or second camera system, the imprint of the container is arranged on a side of the container facing away from the first and / or second camera system.

[0072] The imprint is not in focus of the camera system, which affects the detectability of a particle. Fresenius Kabi Deutschland GmbH FK24117-08-PAT-WO

[0073] Improved. This also prevents the field of vision from being obscured by the print, thus avoiding any obstruction of the view of potential particles.

[0074] In a further development of the invention, the container is turned over before or after the X-raying step.

[0075] In particular, the container is turned over before the X-ray examination step, so that the imprint is located on a side of the container facing away from the third camera system.

[0076] It is specifically intended that the containers, lying on the transport device, are inspected by the first and second camera systems. The printed information is located on the underside of the container, and each camera system is directed at the container from above.

[0077] For X-ray inspection, the container is turned upside down and the third camera system is now directed at the container from below, with the imprint on the top. This easily reduces the influence of the imprint on the automated recognition.

[0078] According to one embodiment, the third camera system can also be arranged in front of the first and second camera systems. In this embodiment of the invention, the containers are preferably fed to the third camera system with the imprint arranged at the top and turned over after the first camera system.

[0079] Turning the container over can be easily achieved, for example, by transporting it from one conveyor belt to another, with a step between the belts. (SoFresenius Kabi Deutschland GmbH FK24117-08-PAT-WO)

[0080] The container tumbles onto the low-lying conveyor belt and turns around.

[0081] In one embodiment of the invention, during the step of scanning the container using the third camera system, the container is arranged between the third camera system and the third light source.

[0082] In this embodiment of the invention, the container is located between the camera system and the light source, which illuminates the container. The camera system's viewing direction is aligned towards the light source in this embodiment.

[0083] In one embodiment of the invention, the third camera system looks directly into the light source.

[0084] In another embodiment of the invention, the at least one light source is arranged on the side of the transport device opposite the camera system and is directed obliquely towards the container.

[0085] In this embodiment of the invention, a contrast plate can be arranged on the side of the container facing away from the third camera system. In this embodiment, the camera system therefore does not look directly at the light source, but rather in the direction of the contrast plate.

[0086] The contrast plate is preferably matte, in particular with a gloss level of G3, preferably G4.

[0087] The contrast plate can be matched to the color of the print on the container. Fresenius Kabi Deutschland GmbH FK24117-08-PAT-WO

[0088] In particular, the contrast plate can be black for containers with black printing and white for containers with white printing.

[0089] In the case of a container with a colored or multicolored imprint, such as red or green, the contrast plate can be colored accordingly, in particular having an a* and / or b* value of + / - 20, preferably + / - 10, particularly preferably + / - 5 of the imprint in the Lab color space.

[0090] In a further embodiment of the invention, during the step of scanning the container using the third camera system, the third light source is arranged on the same side as the camera system.

[0091] In this embodiment, a contrast plate is preferably arranged on a side of the container to be inspected facing away from the third camera system.

[0092] As explained above, the contrast plate can be adapted to the color of the print.

[0093] In this embodiment of the invention, the light source can be located, in particular, on the camera system.

[0094] Preferably, the light source can be designed as a ring light that extends around the camera.

[0095] According to another embodiment, a light source is arranged on the side of the camera system and is directed obliquely towards the container to be inspected.

[0096] In this embodiment of the invention, a shading device is preferably arranged around the camera system, which prevents light from the light source directly entering the camera. Fresenius Kabi Deutschland GmbH FK24117-08-PAT-WO

[0097] In a further embodiment of the invention, the first, second and / or third light source is aligned from one side transversely, in particular perpendicularly to a viewing direction of the first, second and / or third camera system.

[0098] In particular, the light source is positioned to the side of the transport device, while the first, second and / or third camera system is aimed at the container from above or below.

[0099] In particular, a light source can be located on either side of the transport device.

[0100] In this embodiment of the invention, the container can also be arranged between the third camera system and a contrast plate during the step of scanning the container.

[0101] In particular, the viewing direction of the third camera system can be directed from below towards the container, with a contrast plate present above the container.

[0102] Even in the embodiment with a laterally arranged light source, direct light shining into one of the camera systems can be avoided by means of shading.

[0103] In particular, shading devices can be arranged to the side of the transport equipment, which include an opening or window through which light from the side illuminates the container while it is being transported.

[0104] The contrast plate is preferably designed as described above, in particular in the color of the container's imprint and / or with a matte finish. Fresenius Kabi Deutschland GmbH FK24117-08-PAT-WO

[0105] According to another aspect, the invention relates to a method for the optical detection of particles in transparent medical containers.

[0106] The procedure may, in particular, include one or more of the procedural steps described above.

[0107] The medical containers are moved on a transport device, in particular a conveyor belt, the procedure comprising the following steps:

[0108] Inspecting the medical container using a camera system, in particular using the first camera system and / or second camera system,

[0109] Inspecting the medical container using another camera system, in particular using the third Karner system,

[0110] the container is turned over before or after inspection using the additional camera system.

[0111] In particular, the container is inverted, as described above, in such a way that any imprint on the container is placed on the side facing away from the camera system. This reduces the influence of the imprint, especially during AI-based particle detection.

[0112] Preferably, a light source is used during inspection to illuminate the container during the inspection, in particular to shine through it.

[0113] According to another aspect, the invention relates to a method for the optical detection of particles in transparent medical containers. Fresenius Kabi Deutschland GmbH FK24117-08-PAT-WO

[0114] The procedure may, in particular, include one or more of the procedural steps described above.

[0115] The medical containers are moved on a transport device, in particular a conveyor belt, the procedure comprising the following steps:

[0116] Inspecting the medical container using a camera system, in particular using the first camera system and / or second camera system, from above,

[0117] Inspecting the medical container from below using another camera system, in particular the third camera system.

[0118] The viewing direction of at least one camera system, in particular the first camera system and / or the second camera system, is directed downwards towards the container, and the viewing direction of another camera system, in particular the third camera system, is directed downwards towards the container.

[0119] As described above, inspection from above and below can improve the detection of particles that settle downwards.

[0120] Preferably, a light source is used during inspection to illuminate the container, in particular by shining a light through it. Furthermore, according to one embodiment of the method, the container is turned upside down before or after inspection so that the imprint on the camera system following in the transport direction, in particular the third camera system, is turned to the side facing away from the camera system. The invention further relates to a system for inspecting medical containers comprising:

[0121] A transport device, in particular a conveyor belt, for transporting the medical containers; Fresenius Kabi Deutschland GmbH FK24117-08-PAT-WO

[0122] a first camera system directed towards the transport device with a first light source, wherein the transport device comprises a dark background in the area of ​​the first camera system;

[0123] a second camera system directed at the transport device with a second light source, wherein the transport device comprises a bright background in the area of ​​the second camera system,

[0124] as well as a third camera system with a third light source, wherein the third light source is designed to illuminate the containers.

[0125] The system is specifically designed to carry out the procedure described above.

[0126] Preferably, the transport device in the area of ​​the third camera system includes a transmission area for the third light source.

[0127] The area of ​​transmission can be designed, for example, as a gap between two conveyor belts, as an opening in the transport device, or as a transparent section of the transport device.

[0128] The transmission area is designed either in such a way that light from a light source opposite the third camera system can pass through the container or, if the light source is located on the side of the third camera system, that light can pass through the container and fall onto a contrasting plate towards which the viewing direction of the third camera system is directed.

[0129] In a further embodiment of the invention, the transport device includes a step for turning over the containers. Fresenius Kabi Deutschland GmbH FK24117-08-PAT-WO

[0130] The step is preferably located before or after the third camera system, with respect to the direction of transport of the transport device.

[0131] The third camera system is preferably directed downwards towards the transport device, while the first and second camera systems are directed downwards towards the transport device. The container is either rotated by the step in front of the third camera system so that the imprint is then on top, or, if the third camera system is positioned in front of the first and second camera systems with respect to the transport direction, the container is turned over after the third camera system so that the imprint is on the underside.

[0132] The transport device can be arranged in the area of ​​the third camera system between the third camera system and a contrast plate.

[0133] In another embodiment, the transport device is arranged in the area of ​​the third camera system between the third camera system and the third light source.

[0134] In one embodiment of the invention, the first, second and / or third light source is directed obliquely to a viewing direction of the first, second and / or third camera system towards the transport device.

[0135] In this embodiment of the invention, for example, the light source of one of the camera systems can be arranged on the side of the camera system, relative to the transport device, and shine obliquely next to the camera onto the container. Fresenius Kabi Deutschland GmbH FK24117-08-PAT-WO

[0136] In one embodiment of the third camera system, the third light source is arranged on the side of the transport device opposite the third camera system.

[0137] According to another embodiment, the third light source and the third camera system are arranged on the same side of the transport device.

[0138] In another embodiment, in at least one camera system, in particular in the first to third camera systems, the light source is arranged laterally next to the transport device, in particular on both sides.

[0139] In an embodiment of the invention in which the container is not turned over between the camera systems, the third camera system is preferably located between the first and the second camera systems, in particular at a break between two conveyor belts.

[0140] According to another aspect, the invention relates to a system for inspecting medical containers.

[0141] In particular, it may exhibit one or more of the characteristics described above.

[0142] The facility includes

[0143] a transport device, in particular a conveyor belt, for transporting the medical containers;

[0144] a camera system directed at the transport device, in particular the first camera system and / or the second

[0145] Karner a system ;

[0146] a further camera system directed at the transport device, in particular a third camera system,

[0147] where the transport device is located before or after the further Fresenius Kabi Deutschland GmbH FK24117-08-PAT-WO

[0148] The camera system includes a device for turning over the containers.

[0149] The device for turning the containers over can, in particular, be designed as a step between two conveyor belts, as described above.

[0150] According to another aspect, the invention relates to a system for inspecting medical containers.

[0151] In particular, it may exhibit one or more of the characteristics described above.

[0152] The facility includes

[0153] a transport device, in particular a conveyor belt, for transporting the medical containers;

[0154] a camera system directed towards the transport device, in particular a first camera system and / or a second camera system directed from above towards the transport device;

[0155] a further camera system directed at the transport device, in particular a third camera system directed at the transport device from below.

[0156] The system can, particularly in the area of ​​the further camera system directed from below towards the transport device, encompass the transmission area described above.

[0157] Forms of execution:

[0158] 1. Method for the optical detection of particles in transparent medical containers (1), in particular foil bags (1), which are filled with a medical liquid, wherein the medical containers (1) are on a transport device, in particular Fresenius Kabi Deutschland GmbH FK24117-08-PAT-WO

[0159] to be moved on a conveyor belt ( 6a- 6c ), includes the following steps:

[0160] Illuminate a medical container (1) to be inspected with a first light source (3a), wherein the container (1) is inspected at least section by section by means of a first camera system (2a) against a dark background,

[0161] Illuminating the medical container (1) to be inspected with a second light source (3b), wherein the container (1) is inspected at least section by section by means of a second camera system (2b) against a bright background,

[0162] The medical container (1) to be inspected is illuminated with a third light source (3c), wherein the container (1) is inspected at least section by section using a third camera system (2c).

[0163] 2. Method for optically detecting particles in transparent medical containers (1) filled with a medical liquid, in particular according to embodiment 1,

[0164] wherein the medical containers ( 1 ) are moved on a transport device, in particular a conveyor belt ( 6a- 6c ), comprising the steps:

[0165] Inspecting the medical container (1) by means of a camera system, in particular by means of the first camera system (2a) and / or second camera system (2b), inspecting the medical container (1) by means of a further camera system, in particular by means of the third camera system (2c),

[0166] wherein the container ( 1 ) is turned over before or after inspection using the further camera system .

[0167] 3. Method for optical detection of particles in transparent medical containers ( 1 ) equipped with a Fresenius Kabi Deutschland GmbH FK24117-08-PAT-WO

[0168] are filled with medical fluid, in particular according to embodiment 1 and / or 2 ,

[0169] wherein the medical containers ( 1 ) are moved on a transport device, in particular a conveyor belt ( 6a- 6c ), comprising the steps:

[0170] Inspecting the medical container (1) using a camera system, in particular using the first camera system (2a) and / or the second camera system (2b), from above,

[0171] Inspecting the medical container ( 1 ) using another camera system, in particular using the third camera system ( 2c) , from below .

[0172] 4. Method according to one of the preceding embodiments, characterized in that the first camera system (2a ), the second camera system (2b) and the third camera system (2c) comprise a computer system which automatically detects particles present in the medical container (1) to be inspected.

[0173] 5. Method according to one of the preceding embodiments, characterized in that the computer system is equipped with an artificial intelligence which is trained with reference containers into which particles have been introduced.

[0174] 6. Method according to one of the preceding embodiments, characterized in that the container ( 1 ) is inspected from two different sides, in particular from above and from below .

[0175] 7. Method according to one of the preceding embodiments, characterized in that the color of the first, second and / or third light source (3a to 3c) is matched to the color of a print (aa) of the Fresenius Kabi Deutschland GmbH FK24117-08-PAT-WO

[0176] medical container ( 1 ) is adapted .

[0177] 8. Method according to one of the preceding embodiments, characterized in that the dark and / or light background is / are provided by the transport device, in particular by the conveyor belt ( 6a, 6b) .

[0178] 9. Method according to one of the preceding embodiments, characterized in that, during the step of inspecting the container ( 1 ) with the first and / or second camera system (2a, 2b), the imprint ( 1a ) of the container ( 1 ) is arranged on a side of the container ( 1 ) facing away from the first and / or second camera system (2a, 2b).

[0179] 10. Method according to one of the preceding embodiments, characterized in that the container ( 1 ) is turned over before or after the X-raying step, in particular so that the imprint (1a) is arranged on a side of the container ( 1 ) facing away from the third camera system (2c ).

[0180] 11. Method according to one of the preceding embodiments, characterized in that, in the step of scanning the container ( 1 ) by means of the third camera system ( 2c ), the container ( 1 ) is arranged between the third camera system (2c) and the third light source (3c ).

[0181] 12. Method according to one of the preceding embodiments, characterized in that a contrast plate (5) is arranged on a side of the container (1) facing away from the third camera system (3c). Fresenius Kabi Deutschland GmbH FK24117-08-PAT-WO

[0182] 13. Method according to one of the preceding embodiments, characterized in that, in the step of scanning the container ( 1 ) by means of the third camera system ( 2c ), the third light source (3c ) is arranged on the same side as the camera system, wherein a contrast plate (5 ) is arranged on a side of the container ( 1 ) facing away from the third camera system (2c ).

[0183] 14. Method according to one of the preceding embodiments, characterized in that the first, second and / or third light source ( 3a to 3c) illuminates the container ( 1 ) from one side transversely, in particular perpendicularly, to a viewing direction of the first, second and / or third camera system (2a to 2c ).

[0184] 15. Method according to one of the preceding embodiments, characterized in that in the step of scanning the container ( 19 the container ( 1 ) is arranged between the third camera system ( 2c) and a contrast plate (5 ).

[0185] 16. Method according to one of the preceding embodiments, characterized in that the contrast plate (5 ) is provided in a color corresponding to the color of the imprint (1a) on the container (1 ).

[0186] 17. Installation for the inspection of medical containers ( 1 ), in particular designed for carrying out a method according to one of the above embodiments, comprising: A transport device, in particular a conveyor belt ( 6a to 6d ), for transporting the medical containers ( 1 );

[0187] a first camera system (2a) directed towards the transport device with a first light source (3a) ,Fresenius Kabi Deutschland GmbH FK24117-08-PAT-WO

[0188] wherein the transport device in the area of ​​the first camera system ( 2a) comprises a dark background; a second camera system (2b) directed towards the transport device with a second light source (3b) wherein the transport device in the area of ​​the second camera system ( 2b) comprises a bright background; and a third camera system (2c) with a third light source (3c) wherein the third light source (3c) is designed to illuminate the containers ( 1 ).

[0189] 18. Equipment for the inspection of medical containers ( 1 ), in particular according to one of the foregoing embodiments, comprising:

[0190] A transport device, in particular a conveyor belt ( 6a to 6d ), for transporting the medical containers ( 1 );

[0191] a camera system directed towards the transport device, in particular first camera system (2a) and / or second camera system (2b);

[0192] a further camera system directed towards the transport device, in particular a third camera system (2c) wherein the transport device includes a device for turning over the containers before or after the further camera system.

[0193] 19. Equipment for the inspection of medical containers ( 1 ), in particular according to one of the above embodiments, comprising:

[0194] A transport device, in particular a conveyor belt ( 6a to 6d ), for transporting the medical containers ( 1 );

[0195] a camera system directed towards the transport device, in particular a first camera system (2a) and / or a second camera system (2b), which is directed towards the transport device from above; Fresenius Kabi Deutschland GmbH FK24117-08-PAT-WO

[0196] a further camera system directed towards the transport device, in particular a third camera system (2c) which is directed towards the transport device from below.

[0197] 20. System according to one of the above embodiments, characterized in that the transport device in the area of ​​the third camera system ( 2c) comprises a transmission area (7 ).

[0198] 21. Plant according to one of the above embodiments, characterized in that the transport device comprises a stage ( 8 ) for turning over the containers ( 1 ).

[0199] 22. System according to one of the preceding embodiments, characterized in that the transport device is arranged in the area of ​​the third camera system ( 2c) between the third camera system (2c) and a contrast plate (5 ).

[0200] 23. System according to one of the preceding embodiments, characterized in that the first, second and / or third light source ( 3a to 3c) is directed obliquely to a viewing direction of the first, second and / or third camera system ( 2a to 2c) towards the transport device.

[0201] 24. System according to one of the preceding embodiments, characterized in that the third light source (3c) is arranged on the side of the transport device opposite the third camera system (2c),

[0202] or that the third light source (3c) and the third camera system (2c) are arranged on the same side of the transport device. Fresenius Kabi Deutschland GmbH FK24117-08-PAT-WO

[0203] 25. System according to one of the above embodiments, characterized in that the first, second and / or third light source ( 3a to 3c) is / are arranged laterally next to the transport device, in particular on both sides next to the transport device.

[0204] 26. System according to one of the above embodiments, characterized in that the viewing direction of the first and / or second camera system (2a, 2b) is directed from above onto the transport device.

[0205] 27. Systems according to one of the above embodiments, characterized in that the viewing direction of the third camera system (2c) is directed from below towards the transport device.

[0206] 28. System according to one of the above embodiments, characterized in that a shading ( 4 ) for the camera system is arranged in the area of ​​the first, second and / or third camera system ( 2a -2c ).

[0207] 29. System according to one of the preceding embodiments, characterized in that the third camera system (2c) is arranged between the first and second camera systems (2a, 2b) with respect to a conveying direction of the transport device.

[0208] Brief description of the drawings

[0209] The subject matter of the invention will be explained in more detail below with reference to schematic embodiments shown in the drawings Fig. 1 to Fig. 7.

[0210] TIFresenius Kabi Deutschland GmbH FK24117-08-PAT-WO

[0211] Referring to Fig. 1, the design of a schematically depicted medical container, which is to be inspected, will be explained in more detail.

[0212] Figures 2 to 6 are schematic representations of different embodiments of a system according to the invention for inspecting medical containers, which will also be used to explain the method according to the invention in more detail.

[0213] Fig. 7 is an embodiment of the method according to the invention.

[0214] Detailed description of the drawings

[0215] Fig. 1 schematically shows a transparent medical container 1, which is designed here as a foil bag 1 and which is to be examined for any particles that may be present by the inventive method and by the inventive apparatus.

[0216] The foil bag 1 consists of two transparent films which are joined together by weld seams 1c. The foil bag 1 is filled with a medical liquid.

[0217] The foil pouch 1 includes at least one port 1b, which can be used, for example, as a dispensing port to transfer the medical fluid into the patient via a transfer set. The design of such ports 1b is known. These typically include a sealing element that is pressed between a top and a bottom part and which can be pierced with a spike, a needle, or a cannula. One of the ports 1b can also be used to fill the foil pouch 1. Fresenius Kabi Deutschland GmbH FK24117-08-PAT-WO

[0218] Furthermore, the foil bag 1 bears a printed imprint "la". This imprint can include, for example, a product name, a batch number, a barcode, and information about the manufacturing date and / or shelf life. In this embodiment, the imprint "la" is printed in black. There are also imprints printed in white reverse. Additionally, there are imprints printed in multiple colors, such as red or green.

[0219] It has been found that the imprint la has a major influence on the reliability of AI-based optical particle detection as well as on the effort required to train the AI.

[0220] Fig. 2 is a schematic representation of a first embodiment of a system for inspecting medical containers 1 for potentially present particles.

[0221] The system comprises three camera systems 2a-2c. The transport system includes conveyor belts 6a to 6d.

[0222] In this embodiment, the foil bag 1 is first transported on the conveyor belt 6a and passes under the first camera system 2a. The viewing direction of the first camera system 2a is directed downwards towards the foil bag 1 or the conveyor belt 6a.

[0223] A first light source 3a extends around the first camera system 2a. It can, for example, be designed as a ring light or be composed of several lights.

[0224] Between the light source 3a and the camera system 2a there is a shading barrier 4, which prevents light from the Fresenius Kabi Deutschland GmbH FK24117-08-PAT-WO

[0225] Light source 3 falls directly into the lens of camera system 2a.

[0226] The conveyor belt 6a in the area of ​​the first camera system 2a is dark, specifically black. The foil bag 1 is fed to the conveyor belt 6a such that the imprint la is located on the underside, i.e., the side of the foil bag 1 facing away from the first camera system 2a. This reduces the influence of the imprint la when using the image data generated by the first camera system 2a for AI-based particle detection.

[0227] The design of the camera system 2b preferably corresponds to that of the camera system 2a, wherein, in contrast to the conveyor belt 6a, the conveyor belt 6b in the area of ​​the second camera system 2b is bright, in particular white.

[0228] The color of the light sources 3a to 3c is preferably adapted to the color of the imprint la. In the case of a black or white imprint la, the light sources 3a to 3c preferably produce white light.

[0229] With respect to the transport direction according to the camera system 2b, the transport device includes a stage 8, which in this embodiment is formed by the lower conveyor belt 6c.

[0230] The foil bag 1 to be inspected falls from stage 8 at the end of conveyor belt 6b, rotates and now lies on conveyor belt 6c with an upward-facing imprint la .

[0231] In the area of ​​the third camera system 2c, whose viewing direction is directed downwards towards the transport device, Fresenius Kabi Deutschland GmbH FK24117-08-PAT-WO

[0232] A transmission area 7 is located. In this embodiment, the transmission area 7 is provided by a gap between the conveyor belt 6c and the conveyor belt 6d. The width of this gap is so small that the film bag 1 does not fall through, but instead reaches the conveyor belt 6d during transport and is conveyed further by it.

[0233] In this embodiment, the third light source 3c is located on the side of the transport device opposite the third camera system 2c. In this embodiment, the container 1 is illuminated by the light source 3c in the area of ​​the third camera system 2c. The viewing direction of the third camera system 2c is directed towards the light source 3c.

[0234] Inspecting the foil bag 1 from two different sides enables improved recognition accuracy in an AI-based system. This is particularly true when the image data from the first to third camera systems 2a-2c are processed jointly by the AI ​​and assigned to a single container 1.

[0235] Furthermore, turning the foil bag inside out may also improve the capture of particles that tend to settle at the bottom or float on top.

[0236] The embodiment according to Fig. 3 corresponds to the embodiment described in Fig. 2 in the area of ​​the first camera system 2a and in the area of ​​the second camera system 2b. In this embodiment, the system also includes a stage 8 over which the foil bag 1 is turned over.

[0237] In contrast to the embodiment shown in Fig. 2, the third light source 3c is now, with reference to the Fresenius Kabi Deutschland GmbH FK24117-08-PAT-WO

[0238] Transport device, located on the same side as the third camera system 2c. The third camera system 2c looks from below towards the transmission area 7.

[0239] The third light source 3c is arranged to the side of the camera system 2c, and can be formed in particular as a ring light or from an arrangement of several lights.

[0240] In this embodiment, a shading 4 also prevents the light from the third light source 3c from falling directly into the third camera system 2c.

[0241] In this embodiment, a contrast plate 5 is located on the side of the transport device opposite the third camera system 2c. The color of the contrast plate 5 preferably corresponds approximately to the color of the imprint 1a, in this embodiment black.

[0242] In the embodiment shown in Fig. 4, the system in the area of ​​the first camera system 2a and the second camera system 2b is designed according to Fig. 2 and Fig. 3.

[0243] In contrast, the third light source 3c according to Fig. 4 is not oriented obliquely to the third camera system 2c, but the light shines directly towards the transmission area 7 and the contrast plate 5.

[0244] In this way, relative to the power of the light source 3c, a high luminous flux can be provided in the area of ​​the transmission area 7 and thus for the illumination of the foil bag 1.

[0245] The light source 3c is preferably designed as a ring light. Fresenius Kabi Deutschland GmbH FK24117-08-PAT-WO

[0246] In the embodiment shown in Fig. 5, there is no step for turning over the foil bag 1. The first camera system 2a and the second camera system 2b are designed according to the embodiments mentioned above.

[0247] In contrast to the embodiments according to Figs. 2 to 4, the third camera system 2c is located between the first camera system 2a and the second camera system 2b. The transmission area 7 is now located between the conveyor belt 6a, which provides a dark background, and the conveyor belt 6b, which provides a light background.

[0248] In this embodiment as well, the radiation transmission area 7 is provided by a gap between the conveyor belts 6a and 6b.

[0249] The third camera system 2c is directed from below at the transmission area 7 and thus at the foil bag 1 to be inspected.

[0250] In this embodiment, the third light source 3c for the third camera system 2c is located on the side of the transport device opposite the third camera system 2c. The third light source 3c is directed obliquely towards the transport device and thus towards the foil bag 1 to be inspected. This light source can be configured as a ring light or as an arrangement of several lights.

[0251] On the side of the transport device opposite the third camera system 2c, a contrast plate 5 is located above the transmission area 7, which preferably has the color of the imprint 1a. Fresenius Kabi Deutschland GmbH FK24117-08-PAT-WO

[0252] Compared to the embodiments described above, this embodiment is less elaborate; in particular, only two conveyor belts 6a, 6b are required in the area of ​​the three camera systems 2a-2c.

[0253] Fig. 6 is a schematic top view of a further embodiment in which the arrangement of the conveyor belts 6a, 6b and the arrangement of the camera systems 2a to 2c corresponds to the embodiment according to Fig. 5. Shown from above are the first and second camera systems 2a, 2b and the contrast plate (see Fig. 5).

[0254] In contrast to the embodiment shown in Fig. 5, the light sources 3a to 3c are mounted or arranged laterally next to the transport device. The light sources 3a to 3c emit light from the side in the direction of the foil bags 1 moving on the transport device.

[0255] By means of shading 4 with a passage (not shown) the light can be directed specifically only into the area of ​​the foil bags 1.

[0256] Fig. 7 is a flowchart of an embodiment of a method according to the invention, in which a system according to the invention can be used in accordance with one of the embodiments mentioned above.

[0257] First, reference foil bags 1 with and without particles are provided. Particles in the visible size range are then deliberately introduced into specific foil bags.

[0258] These foil bags 1 are used to train the first, second, and third AI-powered camera systems. The AI ​​is manufactured by Fresenius Kabi Deutschland GmbH FK24117-08-PAT-WO

[0259] This informs which reference foil bags contain at least one particle and which do not.

[0260] In particular, the image data from all three camera systems are linked by the AI, which can further improve recognition accuracy. Such an AI-based system may need to be trained on different containers, for example, with regard to size, contents, but also especially with regard to the imprint.

[0261] The system configuration according to the invention can, in particular, reduce the training effort with regard to different imprints 1a on the foil bags 1.

[0262] The now trained AI system can be used in production, for example instead of manual optical inspection by a person, to sort out foil bags 1 in which at least one particle in the visible size range is located.

[0263] Most foil bags 1 do not contain such particles, so they are transported further, packed in secondary packaging and, if necessary, sterilized in the secondary packaging, for example by autoclaving.

[0264] If a foil bag contains at least one visible particle, it is sorted out. Sorting is preferably automated. The rejection rate due to such particles is typically less than 1 ppm.

[0265] The inventive method and system configuration can, in particular, improve the detection of particles in the visible size range using artificial intelligence. Fresenius Kabi Deutschland GmbH FK24117-08-PAT-WO

[0266] Reference symbol list

[0267] 1 container / foil bag with print

[0268] 1b connector

[0269] 1c weld

[0270] 2a first camera system 2b second camera system 2c third camera system 3a first light source

[0271] 3b second light source

[0272] 3c third light source

[0273] 4 Shading

[0274] 5 Contrast plate

[0275] 6a Conveyor belt

[0276] 6b Conveyor belt

[0277] 6c Conveyor belt

[0278] 6d Conveyor belt

[0279] 7 transmission range 8 stage

Claims

Fresenius Kabi Deutschland GmbH FK24117-08-PAT-WO Claims:

1. Method for optically detecting particles in transparent medical containers ( 1 ), in particular foil bags ( 1 ) filled with a medical liquid, wherein the medical containers ( 1 ) are moved on a transport device, in particular a conveyor belt ( 6a-6c ), comprising the steps: Illuminating a medical container (1) to be inspected with a first light source (3a), wherein the container (1) is inspected at least section by section by means of a first camera system (2a) against a dark background, Illuminating the medical container (1) to be inspected with a second light source (3b), wherein the container (1) is inspected at least section by section using a second camera system (2b) against a bright background, X-raying the medical container ( 1 ) to be inspected with a third light source ( 3c ), wherein the container ( 1 ) is inspected at least section by section by means of a third camera system (2c ).

2. Method according to the preceding claim, characterized in that the first camera system (2a), the second camera system (2b) and the third camera system (2c) comprise a computer system which automatically detects particles present in the medical container (1) to be inspected, wherein the computer system is in particular equipped with an artificial intelligence which is trained with reference containers into which particles are introduced. 37 Fresenius Kabi Deutschland GmbH FK24117-08-PAT-WO 3. Method according to one of the preceding claims, characterized in that the container ( 1 ) is inspected from two different sides, in particular from above and from below.

4. Method according to one of the preceding claims, characterized in that the color of the first, second and / or third light source ( 3a to 3c ) is adapted to the color of a print (a ) of the medical container ( 1 ) to be inspected.

5. Method according to one of the preceding claims, characterized in that the dark background and / or the light background is / are provided by the transport device, in particular by the conveyor belt ( 6a , 6b ).

6. Method according to one of the preceding claims, characterized in that, during the step of inspecting the container (1) with the first camera system (2a) and / or with the second camera system (2b), the imprint (1a) of the container (1) is arranged on a side of the container (1) facing away from the first camera system (2a) and / or the second camera system (2b).

7. Method according to one of the preceding claims, characterized in that the container (1) is turned over before or after the X-raying step, in particular so that the imprint (1a) is arranged on a side of the container (1) facing away from the, preferably third, camera system (2c).

8. Method according to one of claims 1 to 7, characterized in that, during the step of scanning the container (1) by means of the third camera system (2c), the 38 Fresenius Kabi Deutschland GmbH FK24117-08-PAT-WO Container (1) is arranged between the third camera system (2c) and the third light source (3c), in particular wherein a contrast plate (5) is arranged on a side of the container (1) facing away from the third camera system (3c).

9. Method according to one of claims 1 to 7, characterized in that, during the step of scanning the container (1) by means of the third camera system (2c), the third light source (3c) is arranged on the same side as the camera system, wherein a contrast plate (5) is arranged on a side of the container (1) to be inspected facing away from the third camera system (2c).

10. Method according to any one of claims 1 to 7, characterized in that the first, second and / or third light source (3a to 3c) illuminates the container (1) from one side transversely, in particular perpendicularly, to a viewing direction of the first, second and / or third camera system (2a to 2c), in particular wherein, in the step of illuminating the container (1), the container (1) is arranged between the third camera system (2c) and a contrast plate (5).

11. Method according to one of the preceding claims, characterized in that the contrast plate ( 5 ) is provided in a color corresponding to the color of the imprint ( 1a ) on the container ( 1 ).

12. System for the inspection of medical containers (1), in particular designed for carrying out a method according to one of the preceding claims, comprising: A transport device, in particular a conveyor belt ( 6a to 6d ), for transporting the medical containers ( 1 ); Fresenius Kabi Deutschland GmbH FK24117-08-PAT-WO a first camera system (2a) directed towards the transport device with a first light source (3a) wherein the transport device comprises a dark background in the area of ​​the first camera system (2a); a second camera system (2b) directed towards the transport device with a second light source (3b) wherein the transport device comprises a bright background in the area of ​​the second camera system (2b) and a third camera system (2c) with a third light source (3c) wherein the third light source (3c) is designed to illuminate the containers (1).

13. System according to the preceding claim, characterized in that the transport device in the area of ​​the third camera system (2c) comprises a transmission area (7 ).

14. System according to one of the preceding claims, characterized in that the third light source ( 3c ) is arranged on the side of the transport device opposite the third camera system (2c ).

15. System according to one of the preceding claims, characterized in that the third camera system (2c) is arranged between the first and second camera systems (2a, 2b) with respect to a conveying direction of the transport device.

16. System according to one of the preceding claims, characterized in that the viewing direction of the third camera system ( 2c) is directed from below towards the transport device.

17. System according to one of the preceding claims, characterized in that the viewing direction of the first Fresenius Kabi Deutschland GmbH FK24117-08-PAT-WO and / or second camera system (2a, 2b) is directed from above at the transport device.

18. System according to one of the preceding claims, characterized in that the transmission area (7) is formed as a gap between the conveyor belts (6a, 6b).

19. System according to one of the preceding claims, characterized in that the transmission area (7 ) is designed as an opening in the transport device (7 ) or as a transparent section of the transport device (7 ).

20. System according to one of the preceding claims, characterized in that the transport device comprises a stage ( 8 ) for turning over the containers ( 1 ).

21. System according to one of the preceding claims, characterized in that the transport device is arranged in the area of ​​the third camera system (2c) between the third camera system (2c) and a contrast plate (5 ).

22. System according to one of the preceding claims, characterized in that the first, second and / or third light source (3a to 3c) is directed obliquely to a viewing direction of the first, second and / or third camera system (2a to 2c) towards the transport device.

23. System according to one of the preceding claims, characterized in that the third light source (3c) and the third camera system (2c) are arranged on the same side of the transport device. Fresenius Kabi Deutschland GmbH FK24117-08-PAT-WO 24. System according to one of the preceding claims, characterized in that the first, second and / or third light source (3a to 3c) is / are arranged laterally next to the transport device, in particular on both sides next to the transport device.

25. Systems according to one of the preceding claims, characterized in that a shading ( 4 ) for the camera system is arranged in the area of ​​the first, second and / or third camera system (2a -2c ). 42

Images