Systems and methods for inspecting products on a production line
A standalone inspection system with an optical scanner verifies product labeling at the terminal end of the production line, addressing mislabeling challenges and ensuring regulatory compliance without disrupting the production flow.
Patent Information
- Authority / Receiving Office
- WO · WO
- Patent Type
- Applications
- Current Assignee / Owner
- AMGEN INC
- Filing Date
- 2026-01-09
- Publication Date
- 2026-07-16
AI Technical Summary
Existing production lines face challenges in accurately verifying product labeling due to potential mislabeling, which can lead to regulatory non-compliance, recalls, and safety risks, while reconfiguring the line to mitigate these issues can disrupt the production flow and cause inefficiencies.
A standalone inspection system with an optical scanner and frame is installed at the terminal end of the production line to verify label presence, requiring minimal structural and operational modifications, allowing for efficient label verification without disrupting the production process.
Ensures accurate labeling of products before they leave the production line, reducing the risk of mislabeling and regulatory non-compliance, while maintaining production efficiency and minimizing installation impact.
Smart Images

Figure US2026010691_16072026_PF_FP_ABST
Abstract
Description
11024-W001-SECSYSTEMS AND METHODS FOR INSPECTING PRODUCTS ON A PRODUCTION LINE CROSS-REFERENCE TO RELATED APPLICATION(S)
[0001] Priority is claimed to United States Provisional Patent Application No. 63 / 743,515, filed January 9, 2025, the entire contents of which are hereby incorporated by reference herein.FIELD OF DISCLOSURE
[0002] The present disclosure generally relates to inspection systems and methods, and, more particularly, systems and methods for inspecting one or more products on a production line.BACKGROUND
[0003] Pharmaceuticals and other products are commonly packaged and labeled to ensure patient and user safety, product authenticity, and traceability. Labels, which may include dosage instructions, batch numbers, expiration dates, barcodes, and / or other important information, often must be accurately affixed to products and verified at various stages of production. Any inadvertent mislabeling, omission, or compromised label integrity can result in regulatory non-compliance, product recalls, and even potentially endanger the patient or user.
[0004] In a busy production environment where multiple tasks are ongoing, the potential exists for products to be mislabeled or left without a label. For instance, labeling equipment may malfunction, operators and laborers may make unintentional mistakes, products may be removed from and then returned to a production line missing their labels or bypassing the labeling process altogether, among other potential issues.
[0005] Reconfiguring or adding a new workstation to an established production line to mitigate the risk of mislabeling may not be practical in many instances. Such modifications can disrupt a calibrated production flow, potentially causing delays or inefficiencies. Moreover, retrofitting a production line may halt production, leading to reduced output and potential delays in meeting demand. In the case of pharmaceutical manufacturing, where high-production runs are commonplace, even minor slowdowns caused by reconfiguring the production line or subsequent troubleshooting can significantly impact productivity, create backlogs, and ultimately increase operational costs.
[0006] To address one or one of the needs and challenges mentioned herein and other related needs and challenges, the present disclosure sets forth advantageous systems and methods for inspecting one or more products on a production line.SUMMARY
[0007] One aspect of the present disclosure provides a system for inspecting one or more products on a production line. The system may include an optical scanner and a frame. The optical scanner may be configured to scan at least one product of the one or more products on the production line at a predetermined inspection location. The frame may be separate from the production line and configured to support the optical scanner adjacent to the at least one predetermined inspection. Furthermore, the frame may include a base and vertical support extending upwardly from the base. A top end or other portion of the vertical support may be configured to support the optical scanner adjacent to the predetermined inspection location. In some embodiments, the system may include a processing subsystem configured to analyze output from the optical scanner to determine at least one characteristic of the at least one product on the production line, including, for example, the presence or absence of one or more labels on the at least one product on the production line.
[0008] Another aspect of the present disclosure provides a method including configuring a system along a production line for inspecting one or more products on the production line, wherein the system may include: an optical scanner configured to scan at least one product of the one or more products on the production line at predetermined inspection location, and a frame separate from the production line and configured to support the optical scanner adjacent to the predetermined inspection location. The frame may include a base and a vertical support extending upwardly from the base, and the vertical support may be configured to support the optical scanner adjacent to the predetermined inspection location. The method may further include operating the11024-W001-SEC system to determine at least one characteristic of the at least one product on the production line. In some embodiments, the at least one characteristic may include the presence or absence of one or more labels on the at least one product on the production line.BRIEF DESCRIPTION OF THE DRAWINGS
[0009] It is believed that the disclosure will be more fully understood from the following description taken in conjunction with the accompanying drawings. Some of the drawings may have been simplified by the omission of selected elements for the purpose of more clearly showing other elements. Such omissions of elements in some drawings are not necessarily indicative of the presence or absence of particular elements in any of the exemplary embodiments, except as may be explicitly delineated in the corresponding written description. Also, none of the drawings are necessarily drawn to scale.
[0010] Fig. 1 is a schematic representation of a system for inspecting one or more products on a production line in accordance with various embodiments of the present disclosure.
[0011] Fig. 2 is a perspective view of a product on a conveyor of a production line in accordance with various embodiments of the present disclosure.
[0012] Fig. 3 illustrates a product label in accordance with various embodiments of the present disclosure.
[0013] Fig. 4 illustrates a perspective view of a system for inspecting one or more products on a production line in accordance with various embodiments of the present disclosure.
[0014] Fig. 5 is a side view of the system illustrated in Fig. 4.
[0015] Fig. 6 is another side view of the system, rotated by 90 degrees from the view in Fig. 5.
[0016] Fig. 7 is an enlarged view of an optical scanner of the system shown in Fig. 4.
[0017] Fig. 8 is a perspective view of a user interface in accordance with various embodiments of the present disclosure.
[0018] Fig. 9 is a perspective view of a stop mechanism in a first mechanical configuration permitting operation of a production line in accordance with various embodiments of the present disclosure.
[0019] Fig. 10 is perspective view of the stop mechanism in Fig. 9 in a second mechanical configuration stopping operation of the production line.
[0020] Fig. 11 is a block diagram illustrating a processing subsystem in accordance with various embodiments of the present disclosure.
[0021] Fig. 12 is a flow diagram of a label presence verification method in accordance with various embodiment of the present disclosure.
[0022] Fig. 13 is a perspective view of a camera and a light source in accordance with various embodiments of the present disclosure.DETAILED DESCRIPTION
[0023] The present disclosure generally relates to systems and methods for inspecting one or more products on a production line. The product may include, for example, a drug, a drug container, a drug delivery device, a medical device, a syringe, a prefilled syringe, a cartridge, an ampoule, a vial, a bottle, an inhaler, an autoinjector, an on-body injector, and / or any other product designed for therapeutic, diagnostic, preventive, and / or supportive medical use. Additionally or alternatively, the product may include packaging such as, for example, primary packaging, secondary packaging, tertiary packaging, a carton, a tray, a blister pack, a pouch, a tube, a crate, a shrink wrap, and / or any other suitable container and / or barrier for storing, transporting, dispensing, and / or other handling of its contents. The production line can take various forms including, for example, an assembly line, a manufacturing line, a pharmaceutical production line, a sterile production line, a fill-finish production line, a drug delivery device production line, a medical device production line, a syringe production line, a tablet production line, a vaccine production line, a bottling line, conveyor(s), and / or any other systematic arrangement of sequential processes and / or workstations where raw materials and / or components are transformed into finished products.11024-W001-SEC
[0024] Inspecting products on a production line is useful to validate, for example, their safety, quality, regulatory compliance, and / or other characteristics, for example, before the products enter the supply chain and / or reach the end user or patient. As an example, inspecting a product on a production line for proper labeling may facilitate, or be required, for patient or user safety, product authenticity, traceability, and / or other requirements relating to regulatory compliance, quality assurance, and / or brand integrity. Once a product enters the supply chain, it can be difficult to verify whether its labeling is accurate or complete.
[0025] To ensure that a finished product leaves a production line with accurate labeling, the inventors have found it advantageous to inspect its labeling as late as possible in the production process and / or as late as possible in a certain stage in the production process, including, for example, at or near the terminal end or final stage of the production line and / or at or near a workstation located immediately or substantially immediately before or upstream of the final packaging station(s) (for example, a boxing station) of the production line. Subsequent to labeling, products may continue to move along the production line where they may encounter various manufacturing processes that may introduce the potential for damage or removal of the label. By inspecting products at or near the terminal end or final stage of the production line or at another late-as-possible location, manufacturers can be more certain that finished products exit the production line and go to final packaging and / or enter the supply chain with appropriate labeling.
[0026] Production lines are often complex in both structure and operation, making modifications challenging and / or potentially resulting in significant costs and / or delays. As there may be limitations on the ability to structurally and / or operationally modify an existing production line, integrating new equipment, such as a final-stage label verification system, into a production line which may not have been originally designed for such can pose significant challenges.
[0027] The presently disclosed systems and methods advantageously allow one to add automated inspection capabilities to an existing (for example, a pre-existing, an operational, an active, an established, and / or an in-place) production line without requiring or substantially minimizing structural and / or operational modification(s) to the production line. The standalone nature of the presently disclosed inspection systems allows them to augment existing equipment on a production line with little or no physical and / or operational interference. Additionally, the relatively compact size of the presently disclosed inspection systems may require minimal installation space and may not increase, or not substantially increase, the footprint of the production line. Furthermore, the presently disclosed inspection systems and methods may be configured for installation at one or more locations along the production line, including, for example, at or near the terminal end or final stage of the production line such as at a terminal workstation along the production line and / or at a workstation located immediately or substantially immediately before or upstream of the final packaging station(s) of the production line. Installing the inspection system, for example, at or near the terminal end or final stage of the production line may allow one to inspect a product immediately or substantially immediately before it leaves the production line, providing a degree of certainty that the product is transferred to final packaging and / or enters the supply chain in a desirable form. Moreover, in some embodiments, the presently disclosed inspection systems and methods may be configured for verifying the presence of one or more labels on one or more products on the production line. In at least some of the embodiments disclosed herein, the product(s) may be moving along the production line, or temporarily positioned stationarily along the production line, when the product(s) are inspected by the presently disclosed inspection systems and methods. These and other advantages will be apparent to one of ordinary skill in the art reviewing the present disclosure.
[0028] Fig. 1 schematically illustrates a system 10 configured to inspect (for example, detect) one or more characteristics of one or more products 12a-c on a production line 14 according to certain embodiments of the present disclosure. The system 10 may be configured to inspect characteristic(s) of the products 12a-c as they are transported by a conveyor 16 of the production line 14 past at least one predetermined inspection location, corresponding approximately to the position of product 12b in Fig. 1. The conveyor 16 may be configured to transport products 12a-c from left to right in Fig. 1, as shown by the darkened arrows. In some embodiments, the conveyor 16 may be configured to stop moving temporarily when one of the products 12a-c is positioned at the predetermined inspection location so that it may be inspected by the system 10; whereas, in other embodiments, the11024-W001-SEC conveyor 16 may be configured to move the products 12a-c continuously through the predetermined inspection location and the system 10 may be configured to inspect the products 12a-c while the move through the predetermined inspection location. Although only three products are illustrated in Fig. 1, it can be understood that a typical production line processes a continuous stream of products similar to those illustrated as products 12a-c in Fig. 1. In some embodiments, the products 12a-c may not be packaged or only partially packaged (for example, positioned in a tray which may later be inserted into a box or carton) when they are inspected by the system 10. In other embodiments, the products 12a-c may include their complete packaging when they are inspected by the system 10.
[0029] The system 10 may be configured for installation at any suitable location along the production line 14 including, for example, at or immediately or substantially immediately upstream of a terminal workstation of the production line 14. In some embodiments, the system 10 may be configured for installation at or near the terminal end of the conveyor 16, as seen in Fig. 1. Accordingly, the system 10 may be configured to inspect the products 12a-c immediately or substantially immediately before the products 12a-c move off of the conveyor 16 to, for example, a collection bin 18 (as seen in Fig. 1), a final packaging station (for example, a boxing station), another conveyor, and / or any other downstream aspect of the production line 14, or to a production process or a post-production process which is performed separately from the production line 14. In some embodiments the system 10 may be configured to inspect the products 12a-c downstream of a final packaging station of the production line 14. In some embodiments, the system 10 may configured to be portable between different locations along the production line 14. In embodiments where the system 10 is disposed at the terminal workstation or final stage of the production line 14 and / or is configured to detect at least the presence of labels 13a-c disposed on, respectively, the products 12a-c, the system 10 may function as a final-stage label verification system.
[0030] In some embodiments, the system 10 may include a frame 20 and an optical scanner 22. The frame 20 may be configured to support the optical scanner 22 adjacent to the predetermined inspection location and / or other location(s) along the production line 14. The frame 20 may be configured to support the optical scanner 22, or a portion thereof, above (for example, directly vertically above) the predetermined inspection location and / or horizontally offset to the side of the predetermined inspection location and / or in any other position adjacent to the predetermined inspection location including vertically below the predetermined inspection location. In some embodiments, the optical scanner 22 may be configured to scan any one or combination of the products 12a-c when located at the predetermined inspection location and / or other location(s) along the production line 14.
[0031] In some embodiments, the frame 20 may be separate, structurally and / or operationally, from the production line 14. So configured, the frame 20 may support, independently of the production line 14, the optical scanner 22 adjacent to the predetermined inspection location. As an example, the frame 20 may be a freestanding (i.e., self-supporting) and / or standalone structure and / or may be configured for installation adjacent to the production line 14 without relying on the production line 14 for mechanical support. Additionally or alternatively, the frame 20 may be configured for installation adjacent to the production line 14 without relying on the production line 14 for mechanical support and / or without directly or indirectly mechanically coupling with the production line 14.
[0032] In some embodiments, the system 10 may have a modular construction, making it relatively easy for one to configure and / or reconfigure the system 10 with various components and / or subsystems, including, for example, adding and / or removing various components and / or subsystems depending on need and / or a particular layout, operation, and / or other characteristic of the production line 14 along which the system 10 is to be installed.
[0033] Fig. 2 illustrates a partially packaged drug delivery device which, in some embodiments, may correspond to any one or each of the products 12a-c illustrated in Fig. 1. The partially packaged drug delivery device in Fig. 2 includes an autoinjector 23 disposed in a tray 25. The autoinjector 23 may be configured to store a drug and, when operated, automatically inject the drug into a patient via a needle, for example, as a subcutaneous injection. The autoinjector 23 may have a generally cylindrical body11024-W001-SEC 29 extending along a longitudinal axis A1. In some embodiments, the autoinjector 23 may be disposed on the conveyor 16 of the production line 14 such that the longitudinal axis A1 is horizontal or substantially horizontal and / or perpendicular or substantially perpendicular to the conveying direction of the conveyor 16.
[0034] One or more labels may be coupled with one or more outer surfaces of the autoinjector 23 and / or the tray 25, including, for example, an outer surface of the cylindrical body 29 of the autoinjector 23. Fig. 3 illustrates a non-limiting example of such a label, designated with reference numeral 31. The label 31 may be coupled with the outer surface of the autoinjector 23 using any suitable method, including, for example, an adhesive, a fastener, and / or being printed and / or stamped directly on the outer surface of the injector 23. In some embodiments, the label 31 may be made of a flexible material including, for example, paper and / or plastic, and may be wrapped around the outer surface of the cylindrical body 29 of the autoinjector 23. In some embodiments, the label 31 may be a sticker. The label 31 may include information pertaining to the autoinjector 23 or other product on which it is placed. In some embodiments, the label 31 may include anyone or combination of: a product logo 31a, a manufacturer logo 31b, drug information 31c (for example, dosage information and / or active pharmaceutical ingredient (API) information), a barcode 31 d, a serial number, instructions for use, and any other identifying, informational, and / or instructional details relating to the product.
[0035] As seen in Figs. 4-6, the frame 20 may include any one or combination of a base 24, a vertical support 26, a first arm 28, a second arm 30, and other structural member(s). In some embodiments, any one or combination of these members may be separate but interconnected (for example, via screw(s) and / or other fastener(s)); whereas, in other embodiments, any one or combination of these members may be integrally formed to define a one-piece structure. In some embodiments, any one or combination of the base 24, vertical support 26, first arm 28, and second arm 30 may be made, partially or entirely, of a rigid material including, for example, metal (for example, steel, stainless steel, aluminum, anodized aluminum, and / or titanium), plastic (for example, polycarbonate), a composite (for example, fiberglass and / or carbon fiber), and / or any other suitable material.
[0036] The base 24 generally may be configured to provide a stable mounting platform for the vertical support 26, a processing subsystem 32, and / or other components of the system 10. As seen in Figs. 2-4, the vertical support 26 may extend upwardly from the base 24 in a vertical or substantially vertical direction, with a bottom end 26 of the vertical support 26 coupled with a top end 24a of the base 24. In some embodiments, the processing subsystem 342 may also be coupled with and / or rest on the top end 24a of the base 24. A bottom end 24b of the base 24 may be configured to rest directly on the ground 8, which may be located, for example, below the production line 14. In some embodiments, the base 24 may be sized and / or dimensioned to fit partially or entirely in the space below (for example, directly vertically below) the conveyor 16 of the production line 14 and / or another portion of the production line 14. So configured, the base 24 may not increase, or substantially minimize any increase to, the footprint of the production line 14. In some embodiments, at least a portion of the base 24 may be positioned below (for example, directly vertically below) the predetermined inspection location, under the conveyor 16.
[0037] In some embodiments, a center of gravity of the frame 20 may be located in the base 24 to prevent or inhibit the frame 20 from tipping over. Additional stability may be provided by configuring the base 24 with a relatively low-profile shape including, for example, a rectangular box-like shape as seen in Figs. 4-6 or a disk-like shape. In some embodiments, when the system 10 is installed along the production line 14, a length LB of the base 24 (corresponding to the longest dimension of the base 24) may be parallel or substantially parallel to the conveying direction of the conveyor 16 and / or a width WB of the base 24 may be perpendicular or substantially perpendicular to the conveying direction of the conveyor 16. In some embodiments, the length LB of the base 24 may be within a range between approximately (e.g., ±10%) 500 mm and 1000 mm, or within a range between approximately (e.g., ±10%) 700 mm and 900 mm, or greater than or equal to approximately (e.g., ±10%) 500 mm, or greater than or equal to approximately (e.g., ±10%) 750 mm, or less than or equal to approximately (e.g., ±10%) 1000 mm, or less than or equal to approximately (e.g., ±10%) 850 mm, or equal to approximately (e.g., ±10%) 802 mm. In some embodiments, the width of the base 24 may be within a range between approximately (e.g., ±10%) 250 mm and 500 mm, or within a range between11024-W001-SEC approximately (e.g., ±10%) 300 mm and 400 mm, or greater than or equal to approximately (e.g., ±10%) 200 mm, or greater than or equal to approximately (e.g., ±10%) 300 mm, or less than or equal to approximately (e.g., ±10%) 500 mm, or less than or equal to approximately (e.g., ±10%) 400 mm, or equal to approximately (e.g., ±10%) 344 mm, or any other suitable dimension.
[0038] In some embodiments, the vertical support 26 may have a generally linear shape such as a bar or post and / or any other shape suitable for supporting the optical scanner 22 adjacent to the predetermined inspection location. In some embodiments, the top end 26a of the vertical support 26 may be coupled, directly or indirectly, with the optical scanner 22 to support the optical sensing system 22 above the predetermined inspection location. In some embodiments, the vertical support 26 may have a height HVS measured vertically within a range between approximately (e.g., ±10%) 500 mm and 2000 mm, or within a range between approximately (e.g., ±10%) 1000 mm and 15000 mm, or greater than or equal to approximately (e.g., ±10%) 750 mm, or greater than or equal to approximately (e.g., ±10%) 1000 mm, or less than or equal to approximately (e.g., ±10%) 2000 mm, or less than or equal to approximately (e.g., ±10%) 1500 mm, or equal to approximately (e.g., ±10%) 1300 mm, or any other suitable dimension.
[0039] In some embodiments, the first arm 28 may extend horizontally or substantially horizontally from the top end 26 of the vertical support 26 and / or may be configured to cantilever the optical scanner 22 over the predetermined inspection location and / or another portion of the production line 14. In some embodiments, a first end 28a of the first arm 28 may be coupled with the top end 26 of the vertical support 26 and a second end 28b of the first arm 28 may be coupled with the optical scanner 22. Furthermore, in certain such embodiments: the first end 28a of the first arm 28 may be adjustably coupled with the top end 26 of the vertical support 26 such that the first arm 28 can move vertically, horizontally, and / or rotationally with respect to the vertical support 26; and / or the second end 28b of the first arm 28 may be adjustably coupled with the optical scanner 22 such that the optical scanner 22, or certain part(s) thereof, can move vertically, horizontally, and / or rotationally with respect to the first arm 28. These adjustable connection(s) may allow one to adjust the position of the optical scanner 32 relative to the predetermined inspection location to optimize its ability to scan the products 12a-c on the production line 14. In other embodiments, the first end 28a of the first arm 28 may be fixedly coupled with the vertical support 26 such that the first arm 28 cannot move relative to the vertical support 26 and / or the second end 28b of the first arm 28 may be fixedly coupled with the optical scanner 22 such that the optical scanner 22 cannot move relative to the first arm 28.
[0040] The first arm 28 may be dimensioned to cantilever the optical scanner 22 over the predetermined inspection location while maintaining a compact overall design of the frame 20. Accordingly, in some embodiments, the first arm 28 may have a length LFA measured horizontally within a range between approximately (e.g., ±10%) 100 mm and 500 mm, or within a range between approximately (e.g., ±10%) 200 mm and 400 mm, or greater than or equal to approximately (e.g., ±10%) 100 mm, or greater than or equal to approximately (e.g., ±10%) 200 mm, or less than or equal to approximately (e.g., ±10%) 500 mm, or less than or equal to approximately (e.g., ±10%) 400 mm, or equal to approximately (e.g., ±10%) 312 mm. Furthermore, in some embodiments, a top end of the first arm 28 may be spaced apart from a top end of the conveyor 16 by a vertical distance D1 within a range between approximately (e.g., ±10%) 200 mm and 500 mm, or within a range between approximately (e.g., ±10%) 300 mm and 400 mm, or greater than or equal to approximately (e.g., ±10%) 200 mm, or greater than or equal to approximately (e.g., ±10%) 300 mm, or less than or equal to approximately (e.g., ±10%) 500 mm, or less than or equal to approximately (e.g., ±10%) 400 mm, or equal to approximately (e.g., ±10%) 390 mm, or any other suitable dimension.
[0041] In some embodiments, the second arm 30 may be configured to maintain a predetermined distance between the vertical support 26 and a particular section of the production line 14, thereby facilitating, for example, installation of the system 10 at predetermined location along the production line 14, including, for example, at an optimal location for inspecting the products 12a-c as they are transported by the conveyor 16. The second arm 30 may extend horizontally or substantially horizontally from the vertical support 26 and / or in a direction that is perpendicular or substantially perpendicular to the first arm 28. Furthermore, in11024-W001-SEC some embodiments, the second arm 30 may be coupled with the vertical support 26 at a location below where the first arm 26 coupled with the vertical support 26. Further still, in some embodiments, the second arm 30 may be omitted.
[0042] In some embodiments, the second arm 30 may have a length LSA measured horizontally within a range between approximately (e.g., ±10%) 100 mm and 500 mm, or within a range between approximately (e.g., ±10%) 200 mm and 400 mm, or greater than or equal to approximately (e.g., ±10%) 100 mm, or greater than or equal to approximately (e.g., ±10%) 200 mm, or less than or equal to approximately (e.g., ±10%) 500 mm, or less than or equal to approximately (e.g., ±10%) 400 mm, or equal to approximately (e.g., ±10%) 362 mm, or any other suitable dimension.
[0043] The optical scanner 22 generally may be configured to convert light and / or other optical signal(s) from a physical object into digital signal(s) for further analysis, storage, and / or other processing. In some embodiments, the optical scanner 22 may include, for example, any one or combination of: one or more cameras, one or more color detectors, and one or more other optical sensors. In some embodiments, the optical scanner 22 may include a camera 34 and a color detector 36 as shown in the figures. The camera 34 may be any suitable device configured to capture one or more images of a physical object, including, for example, a still camera, a video camera, a high-speed camera, an area scan camera, and / or a line scan camera. The color detector 36 may be any suitable device configured to identify and / or measure color information from a physical object including, for example, a red-green-blue (RGB) color detector, a multispectral color detector, a hyperspectral color detector, a colorimeter, a photodiode-based color detector, and / or a camera. In some embodiments, the camera 22 and the color detector 36 may be configured to simultaneously or substantially simultaneously scan a physical object (including, for example, one or more of the products 12a-c) located at the predetermined inspection location. Furthermore, in some embodiments, output from the color detector 36 may directly or indirectly cause: the camera 34 to capture at least one image of the at least one product located at the predetermined inspection location and / or the processing system 32 to analyze at least one image captured by the camera 34 of the at least one product located at the predetermined inspection location. So configured, the color detector 36 may streamline data processing and / or reduce data storage and / or power requirements for the processing system 32.
[0044] In some embodiments, the camera 34 and the color detector 36 may be aligned or substantially aligned with each other in the conveying direction of the conveyor 16, such that their field of view is the same or substantially the same, or at least overlapping. As seen in Figs. 4, 5, and 7, in some embodiments, the camera 34 and the color detector 36 each may be coupled with the first arm 28. In some embodiments, the camera 34 and / or the color detector 36 may be adjustably coupled with first arm 28 such that it / they can move vertically, horizontally, and / or rotationally with respect to the first arm 28. In some embodiments, the camera 34 be coupled with the first arm 28 at a location which is closer in the horizontal direction to the vertical support 26 than the location where the color detector 36 is coupled with the first arm 28, or vice versa depending on what a particular application may require. As illustrated in Fig. 5, in some embodiments, the camera 34 may be coupled with the first arm 28 such that a bottom end of the camera 34 may be spaced apart from a top end of the conveyor 16 by a vertical distance D2 within a range between approximately (e.g., ±10%) 50 mm and 350 mm, or within a range between approximately (e.g., ±10%) 150 mm and 250 mm, or greater than or equal to approximately (e.g., ±10%) 50 mm, or greater than or equal to approximately (e.g., ±10%) 150 mm, or less than or equal to approximately (e.g., ±10%) 350 mm, or less than or equal to approximately (e.g., ±10%) 250 mm, or equal to approximately (e.g., ±10%) 199 mm, or any other suitable dimension. In some embodiments, the color detector 36 may be coupled with the first arm 28 such that a bottom end of the color detector 36 may be spaced apart from a top end of the conveyor 16 by a vertical distance D3 within a range between approximately (e.g., ±10%) 100 mm and 400 mm, or within a range between approximately (e.g., ±10%) 200 mm and 300 mm, or greater than or equal to approximately (e.g., ±10%) 100 mm, or greater than or equal to approximately (e.g., ±10%) 200 mm, or less than or equal to approximately (e.g., ±10%) 400 mm, or less than or equal to approximately (e.g., ±10%) 300 mm, or equal to approximately (e.g., ±10%) 233 mm, or any other suitable dimension.11024-W001-SEC
[0045] In some embodiments, the camera 34 may be configured to capture images in grayscale. Grayscale imaging may, for example, promote image uniformity and / or reduce sensitivity to variations in label color, ink color, and / or background coloration, which may improve robustness for downstream processing such as decoding, character recognition, feature extraction, segmentation, and / or quality grading across labels having different colors or printing schemes. In other embodiments, the camera 34 may be configured to capture images in color (for example, RGB) or in any other suitable format, such as mu Itispectral, hyperspectral, and / or infrared, depending on the desired imaging performance and / or characteristics of the labels being imaged.
[0046] In some embodiments, the camera 34 may have a resolution of approximately (for example, ±10%) 5 megapixels (MP). In one example, the camera 34 may have a resolution of about 2448 x 2048 pixels, although other resolutions may be used. In some embodiments, the camera 34 may be configured to capture images at a maximum frame rate of about 26 frames per second (FPS), for example, at the mentioned resolution. In other embodiments, the camera 34 may operate at higher or lower frame rates and / or may provide variable frame rates depending on exposure time and / or other camera settings.
[0047] In some embodiments, the camera 34 may include a lens having one or more of the following characteristics: a focal length of approximately (for example, ±10%) 12 mm, a mounting type of C-mount, manual focus, manual aperture, working distance (i.e. a distance between the lens and the predetermined inspection location) of approximately (for example, ±10%) 240 mm, afield of view height of approximately (for example, ±10%) 143 mm, and a field of view width of approximately (for example, ±10%) 171 mm.
[0048] In some embodiments, the system 10 may include a light source, such as the light source 70 depicted in Fig. 13, which may be configured to illuminate (for example selectively illuminate) the predetermined inspection location to facilitate, for example, detection, imaging, and / or analysis of the product(s) at the predetermined inspection location. In certain such embodiments, the processing subsystem 32 may be configured to activate the light source 70 to illuminate the predetermined inspection location in response to a determination by the processing subsystem 32 that one or more products are currently located at the predetermined inspection location. For example, if, based on output from the color detector 36, the processing subsystem 32 determines that one or more products are currently located at the predetermined inspection location, the processing subsystem 32 may activate or otherwise control the light source 70 to illuminate the predetermined inspection location. In some embodiments, the processing subsystem 32 may additionally control one or more illumination parameters of the light source 70, including, for example, brightness, pulse width, duty cycle, strobe timing, wavelength, color temperature, and / or illumination pattern, to suit, for example, the type of product, the speed of the production line, and / or the inspection modality.
[0049] In some embodiments, the light source 70 may be configured to provide selective illumination, meaning the light source 70 is activated only during time periods when a product (or products) present at the predetermined inspection location, and may be deactivated or operated at reduced output at other times. Selective illumination may reduce power consumption and / or heat generation and / or may improve measurement repeatability by providing more consistent lighting conditions during inspection.
[0050] In some embodiments, the light source 70 may comprise a diffused light emitting diode (LED) light panel and / or comparable light source configured to emit light toward at least the predetermined inspection location. In some embodiments, the light source 70 may be configured to homogenously or substantially homogenously illuminate the product(s) at or near the predetermined inspection location. Furthermore, in some embodiments, the light source 70 may be configured to reduce or eliminate specular reflection or glare from the reflective surfaces of the product and / or its packaging, including, for example, from trays and / or glass vials. In some embodiments, the light source 70 may be configured to emit white or substantially white light, powered approximately 24 volts at 1.5 amperes, have an overdrive maximum voltage of 48 volts, have an overdrive maximum current of 3 amperes, have a pulse duration of below 1 ms, and / or have a maximum pulse duration of 10 ms.11024-W001-SEC
[0051] In some embodiments, the light source 70 may have a central opening 72. In certain such embodiments, the central opening 72 may extend through the light source 70 between opposite sides of the light source 70 (for example, from an upper side to a lower side of the light source 70). In some embodiments, the camera 34 may be positioned relative to the light source 70 such that at least a portion of the camera 34 (for example, a lens, lens barrel, housing, and / or other optical component) is disposed partially or entirely within the central opening 72. Additionally or alternatively, the camera 34 may be arranged such that an optical axis of the camera 34 passes through the central opening 72, for example, so that the camera 34 can view the predetermined inspection location along a line of sight that is coaxial with, or substantially coaxial with, the opening 72. In certain such embodiments, the light source 70 may provide illumination generally around the line of sight of the camera 34, which can promote more uniform illumination of the imaged field of view and / or reduce shadows. In Fig. 13, the camera 34 is disposed above the light source 70 and oriented such that its optical axis passes through the central opening 72. In this configuration, the light source 70 is positioned between the camera 34 and the target region while maintaining the optical path of the camera 34 through the opening 72.
[0052] In some embodiments, the system 10 may include a user interface 38 (Fig. 8) configured to enable a user to communicate with and / or control the system 10. The user interface 38 may include, for example, any one or combination of: graphical display(s) (for example, a liquid crystal display (LCD) monitor, a touchscreen, etc.), input element(s) (for example, a keypad, a keyboard, buttons, knobs, etc.), light(s), speaker(s), and alarm(s) (for example, a bell, horn, and / or flashing light). In some embodiments, the user interface 38 may be configured to display a real-time or substantially real-time image of the product located at the predetermined inspection location. In some embodiments, this image may be overlaid with and / or positioned adjacent to visual representation(s) of the image analysis performed by the processing subsystem 32. For example, such visual representation(s) may include any one or combination of: a symbol and / or text indicating the presence of a label on the product, an instructional prompt for the user (for example, text stating “add label” ad / or “remove product from conveyor”), status information related to the image analysis performed by the processing subsystem 32 (for example, text stating “label verification complete”), identification information relating to the product (for example, text indicating a serial number and / or other information read from a barcode on the label on the product), and other information. The user interface 38 may be coupled with the frame 20 in some embodiments. Furthermore, in some embodiments, the user interface 38 may be omitted.
[0053] In some embodiments, the user interface 38 may include a display screen 60 and / or a signal element 62. In some embodiments, the display screen 60 may include an LCD monitor and / or may be configured to display graphics and / or text. In some embodiments, the display screen 60 may have touchscreen capabilities. In some embodiments, the signal element 62 may include one or more lights selectively activatable depending on an operational state of the system 10. For example, a green light of the signal element 62 may be activated if the system 10 and / or production line 14 is operating normally, and / or a red light of the signal element 62 may be activated if the system 10 is operating abnormally and / or the production line 14 has stopped due to system 10 detecting missing and / or misplaced label(s) on one or more of the products on the production line 14. In some embodiments, the signal element 62 may include a speaker and / or other sound generating element(s) to alert an operator of missing and / or misplaced label(s), product line stoppage, and / or any other condition requiring operator attention.
[0054] In some embodiments, the system 10 may include one or more push buttons allowing an operator to manually start, stop, and / or reset the system 10. In some embodiments, the one or more buttons may be integrated into the user interface 38 or may be separate from the user interface 38.
[0055] In some embodiments, the system 10 may include a stop mechanism 40 configured to stop operation of the conveyor 16 and / or another aspect of the production line 14 when activated. In some embodiments, the stop mechanism 40 may be configured as a machine stop. The stop mechanism 40 may be coupled, directly or indirectly, to the conveyor 16, a controller for controlling operation of the conveyor 16, a power source powering the conveyor 16, and / or another aspect of the production line 14. In some embodiments, the stop mechanism 40, when activated, may transform from a first mechanical configuration (Fig. 9),11024-W001-SEC where the stop mechanism 40 allows operation of the conveyor 16 and / or other aspect(s) of the production line 14, to a second mechanical configuration (Fig. 10), where the stop mechanism 40 stops (for example, mechanically stops and / or electrically stops) operation of the conveyor 16 and / or other aspect(s) of the production line 14. Additionally or alternatively, the stop mechanism 40, when activated, may be configured to electronically (for example, through programmed and / or hardwired features) stop operation of the conveyor 16 and / or other aspect(s) of the production line 14 when activated. In some embodiments, the stop mechanism 40 may be configured to merely slow operation of the conveyor 16 (for example, reduce the conveying speed of the conveyor 16) when activated, instead of bringing the conveyor 16 to a complete halt.
[0056] In some embodiments, the stop mechanism 40 may include an actuator 64 configured such that, when the stop mechanism is activated, the actuator 64 mechanically blocks (for example, occludes or interrupts a light beam and / or sensing field), clears (for example, ceases to obstruct a light beam and / or sensing field), engages, clears and / or otherwise interacts with a sensing element (for example, a pre-existing sensing element) of the production line 14 (for example, an eject bin full sensor), which, in turn, may cause the production line 14 to cease conveying products through the predetermined inspection location and / or otherwise halt operation of the production line 14. For example, the actuator 64 may be configured to move into contact with, occlude, depress, or otherwise mechanically actuate an eject bin full sensor and / or other sensing element that is already part of the production line 14. Actuation of the sensing element may cause the sensing element to output a corresponding stop / fault signal to a production line controller (for example, a programmable logic controller and / or control circuit). In response to receiving that signal, the production line 14 may automatically transition to a stopped state, such as by disabling one or more conveyors, pausing infeed, and / or otherwise preventing products from being conveyed through the predetermined inspection location. In this manner, the stop mechanism 40 leverages existing production line sensors and control logic to halt product flow without requiring direct electrical integration of the stop mechanism 40 into the controller.
[0057] In some embodiments, the actuator 64 may include a pneumatic cylinder and / or a solenoid. In certain such embodiments, the pneumatic cylinder may include an end effector (for example, a flag, tab, and / or other blocking element) configured to interact with a sensing field (for example, a light beam or detection zone) of the pre-existing sensing element. In some embodiments, this may be accomplished without physically contacting a fragile or calibrated portion of the sensing element, thereby reducing wear and avoiding sensor damage or misalignment. For example, the end effector may be configured to interrupt a light beam at a spaced distance from a sensor housing rather than striking the sensor itself. In some embodiments, the pneumatic cylinder may be double-acting pneumatic cylinder configured to exert force in both an extending direction and a retracting direction, thereby providing controlled deployment and controlled retraction of the end effector. In some embodiments, the pneumatic cylinder may be configured for operation at a maximum supply pressure of approximately (for example, ±10%) 10 bar and / or have a stroke length of approximately (for example, ±10%) 40 mm. In some embodiments, the actuator 64 may be configured to achieve a reaction time of less than about one second from receipt of an activation command to achieve a stopinducing position relative to the pre-existing sensing element.
[0058] In embodiments where the actuator 64 includes a solenoid, the solenoid may be configured to control pneumatic flow to the pneumatic cylinder by opening and / or closing an air valve to drive the cylinder in the extending direction and / or the retracting direction. In some embodiments, the solenoid valve may be normally closed or normally open, and / or may be configured to provide fail-safe behavior such that loss of power and / or loss of air pressure causes the actuator 64 to default to a retracted position or, in other embodiments, to a deployed position depending on application requirements. In some embodiments, the stop mechanism 40 may include a pressure sensor configured to detect a loss of air supply to the pneumatic cylinder. In some embodiments, in response to detecting a loss of air supply to the pneumatic cylinder of the stop mechanism 40, the pressure sensor may be configured to output a signal to the signal element 62 causing the signal element 62 to activate an alarm (for example, a red light and / or a loud sound).11024-WC01-SEC
[0059] In some embodiments, signal(s) output by the camera 34, color detector 36, and / or other feature(s) of the optical scanner 22 may be received by the processing subsystem 32 which then, based on the received signal(s), previously stored data, and / or other input(s), may be configured to (for example, programmed to and / or hardwired to) execute one or more software and / or hardware processes and / or output control signal(s) and / or data to various device(s), subsystem(s), and / or other aspect(s) of the system 10, the production line 14, and / or other system(s). In some embodiments, the processing subsystem 32 may be configured to (for example, programmed to and / or hardwired to) analyze one or more signals output from the optical scanner 22 to determine one or more characteristics of one or more products (for example, the products 12a-c) on a production line (for example, production line 14) at a predetermined inspection location, including, for example, any one or combination of the characteristics described herein and / or other characteristic(s). The processing subsystem 32 may perform these functions in real-time, or substantially in real-time, while, for example, the product is disposed at the predetermined inspection location.
[0060] In some embodiments, the processing subsystem 32 may take the form of a general purpose or special purpose computer, or any other suitable computing device. Furthermore, in some embodiments, the processing subsystem 32 may include a programmable logic controller, a desktop computer, a laptop computer, a tablet computer, a smartphone, a server, or some combination thereof. The processing subsystem 32 may be physically integrated into the system 10 as shown in Fig. 1; or, in other embodiments, may be a standalone device or may be distributed across multiple systems or devices including optionally the system 10. In some embodiments, the processing subsystem 32 may be an electrical device (for example, a hard-wired circuit and / or circuit component), a combination of electrical devices, a mechanical device, a combination of mechanical devices, or a combination of mechanical and electrical devices. In some embodiments, the processing subsystem 32 may include one or more processors (for example, microprocessors). Furthermore, in some embodiments, the processing subsystem 32 may not include a physical processor or other physical components and may be configured as a program module consisting of a set of non-transitory computer-readable instructions to be executed by one or more processors of a computer on which the program module is installed.
[0061] Fig. 11 is a block diagram illustrating various elements of an embodiment of the processing subsystem 32, as well as its coupling to various other elements of the system 10. The processing subsystem 32 may be coupled with (for example, via wireless and / or wired communications) any one or combination of: the optical scanner 22 (including, the camera 34 and / or the color detector 36), the user interface 38, the stop mechanism 40, and additional element(s) of the system 10 and / or the production line 14. The processing subsystem 32 may include any one or combination of: a central processing unit (CPU) 50, a memory 52, an input / output (I / O) interface 54, a communication device 56, a power supply 58, and other software and / or hardware elements. Other embodiments of the processing subsystem 32 may have additional or fewer element(s) than those illustrated in Fig. 11 and / or additional or fewer coupling(s) than those illustrated in Fig. 11.
[0062] In some embodiments, the CPU 50 may include one or more processors (for example, microprocessors) configured to execute one or more software programs associated with the system 10, including, for example, one or more sets of non-transitory computer-readable instructions.
[0063] In some embodiments, the memory 52 may include a non-transitory computer-readable storage medium configured to store data, including, for example, non-transitory computer-readable instructions constituting one or more services or programs and any data operated on or produced by such services or programs. The memory 52 may store the data on a volatile (for example, RAM) and / or non-volatile memory (for example, a hard disk), and may be a removable or non-removable memory. In some embodiments, one or more processors of the CPU 50 may be configured to fetch and execute the instructions stored in the memory 52 in order to perform various functions and methods described herein, including, for example, analyzing signal(s) from the optical scanner 22 to determine one or more characteristics of one or more products on the production line 14 at a predetermined inspection location.11024-W001-SEC
[0064] In some embodiments, the I / O interface 54 may be configured to communicatively couple the processing subsystem 32 with various device(s) to facilitate data communications therebetween, including, for example, communicatively coupling the processing subsystem 32 with any one or combination of: the optical scanner 22 (including, the camera 34 and / or the color detector 36), the user interface 38, the stop mechanism 40, and additional device(s) and / or subsystem(s) of the system 10 and / or the production line 14.
[0065] In some embodiments, the communication device 56 may be configured to establish communication with external devices via a network (for example, a manufacturing intranet and / or the Internet) and may include an antenna for wireless communications, a port for a wired connection, a connection to a modem, a connection to a router (for example, a wireless router), or some combination thereof. In some embodiment embodiments, the communication device 56 may be configured to transmit the results of an inspection performed by the system 10 to an external device such as, for example, a remote computing device (for example, a server or database operated by a manufacturer) and / or a local computing device (e.g., a user’s personal computer, smartphone, tablet, etc.).
[0066] In some embodiments, the processing subsystem 32 may be configured to (for example, programmed to and / or hardwired to) analyze one or more signals output from the optical scanner 22 (for example, from the camera 34 and / or color detector 36) to determine the presence or absence of one or more labels (for example, label 31) on one or more products (for example, the products 12a-c) on a production line (for example, the production line 14) at, for example, one or more predetermined inspection locations (for example, the predetermined inspection location in Fig. 1). In certain such embodiments, the memory 52 and / or another element of the processing subsystem 32 may store one or more reference images of, for example, the intended appearance of the one or more labels on the one or more products and / or the one or more labels by themselves. The one or more reference images may be stored in a reference image library in the memory 52 and / or another element of the processing subsystem 32, for example, prior to and / or substantially simultaneously with the time when the optical scanner 22 captures one or more images of the one or more products on the production line. In some embodiments, the CPU 50 and / or another element of the processing subsystem 32 may be configured to compare image(s) captured by the camera 34 of the product(s) on the production line with the reference image(s) stored in the memory 52 to determine characteristic(s) of the product(s) on the production line, including, for example, the presence or absence of label(s) on the product(s) on the production line (for example, label 31 in Fig. 2). Additionally or alternatively, in some embodiments, the CPU 50 and / or another element of the processing subsystem 32 may be configured to feed the image(s) captured by the camera 34 of the product(s) on the production line to a neural network to determine the presence or absence of the label(s) on the product(s) on the production line. In certain such embodiments, the neural network may have been trained with, for example, image(s) of the intended appearance of the label(s) on the product(s) and / or the label(s) by themselves.
[0067] In some embodiments, the processing subsystem 32 may control the timing of various functions of the system 10, including, for example: (a) when the camera 34 captures one or more images of the predetermined inspection location; and / or (b) when the CPU 50 analyzes the one or more images captured by the camera 34 of the predetermined inspection location. By controlling the timing of (a), (b), and / or other functions of the system 10, the processing subsystem 32 may streamline the process of determining the characteristic(s) of the product(s) at the predetermined inspection location, as compared to having the processing subsystem 32 monitor a continuous stream of images of the predetermined inspection location, where a product may not always be present due to, for example, spacing between the products on the production line. Accordingly, the processing subsystem 32 may be configured to determine the characteristic(s) of the product(s) at the predetermined inspection location with increased speed, less data processing, a smaller reference image library, lower power requirements, less complexity, and / or other operational advantages.
[0068] In some embodiments, the processing subsystem 32 may be configured to determine if one or more products on the production line is / are located at the predetermined inspection location based on output from the color detector 36. As an11024-W001-SEC example, if an outer surface of the product is yellow, the processing subsystem 32 may be configured to determine that the product is present at the predetermined inspection location only if the color detector 36 outputs a signal indicating the presence of a yellow object. In some embodiments, only if the processing subsystem 32 has determined that the product(s) are present at the predetermined inspection location may the processing subsystem 32 process with analyzing image(s) captured by the camera 36 of the predetermined inspection location to, for example, determine characteristic(s) of the product(s) at the predetermined inspection location, including, for example, the presence or absence of label(s) on the product(s) at the predetermined inspection location.
[0069] In some embodiments, the processing subsystem 32 may be configured to output one or more signals (for example, control signals) to one or more elements of the system 10, the production line, and / or other device(s) and / or system(s) in response to a determination by the processing subsystem 32 and / or another system of the presence and / or absence of one or more characteristic(s) of the product(s) on the production line at the predetermined inspection location. In certain such embodiments, in response to a determination that label(s) is / are absent from the product(s) at the predetermined inspection location, the processing subsystem 32 may be configured to output one or more signals (for example, control signals) for: stopping or slowing operation of the conveyor 16 and / or other aspect(s) of the production line 14; and / or activating an alarm for notifying an operator, worker, and / or other individual working on the production line 14 of the missing or misplaced label(s) (including, for example, an alarm sound, light, and / or display generated by the user interface 38). Furthermore, in certain such embodiments, in response to a determination that label(s) is / are absent from the product(s) at the predetermined inspection location, the processing subsystem 32 may be configured to output a control signal for activating the stop mechanism 40, causing it to transform from the first mechanical configuration (Fig. 9), where the stop mechanism 40 allows operation of the conveyor 16 and / or other aspect(s) of the production line 14, to the second mechanical configuration (Fig. 10), where the stop mechanism 40 stops operation of the conveyor 16 and / or other aspect(s) of the production line 14. Accordingly, the product(s) with the missing or misplaced label(s) can be removed from the conveyor 16 and / or coupled with the appropriate label(s), for example, manually by a worker and / or automatically by a machine.
[0070] Although the foregoing may emphasize use of the processing subsystem 32 to determine the presence of label(s) on product(s) on a production line, the processing subsystem 32 may, additionally or alternatively, be configured to determine a variety of other characteristic(s) of the products(s) on the production line. In some embodiments, the processing subsystem 32 may be configured to determine, for example, any one or combination of the following characteristic(s): placement, legibility, and / or other details of label(s) on product(s) on the production line; physical defect(s) in product(s) on the production line (for example, cracks, breakages, warping, surface abnormalities, color abnormalities, etc.); and a count (for example, a tally, an enumeration, etc.) of the drug container(s) or other items disposed in a tray or other container or packaging on the production line.
[0071] The system 10 and variants thereof may be used in various methods for inspecting product(s) and / or other object(s) on a production line. Fig. 12 is a flow diagram of a method 100 of verifying the presence of one or more labels (for example, label 31) on and / or other characteristic(s) of one or more products (for example, products 12a-c) on a production line (for example, production line 14) according to certain embodiments of the present disclosure. Any one or combination of the steps illustrated in Fig. 12 and described below may be omitted depending on the specific requirements of a particular application. Additional steps are also possible. Furthermore, although the flow diagram in Fig. 12 illustrates a particular sequence of steps, any one or combination of the steps may be carried out in a different sequence, depending on what a particular application may require. Moreover, in some embodiments, certain steps from the flow diagram may be executed simultaneously or in parallel.
[0072] In some embodiments, the method 100 may begin with selecting (for example, determining) one or more locations along the production line for inspecting product(s) on the production line (block 102 in Fig. 12). In some embodiments, this step may be performed by an operator of the production line. The inspection location(s) may be any suitable location along the11024-W001-SEC production line, including, for example, at or near the terminal end or final stage of the production line such as at a terminal workstation along the production line and / or at a workstation located immediately or substantially immediately before or upstream of the final packaging station(s) of the production line.
[0073] Next, in some embodiments, the method 100 may include configuring the system 10 along the production line for inspecting the product(s) on the production line at the predetermined inspection location(s) (block104 in Fig. 12). In some embodiments, this step may involve installing the system 10 along the production line such that: the system 10 does not structurally modify, or does not substantially modify, the production line; the frame 20 and / or other portion(s) of the system 10 do not directly or indirectly mechanically couple with the production line; and / or the frame 20 and / or other portion(s) of the system 10 do not rely on the production line for mechanical support. Furthermore, in some embodiments, this step may involve: arranging the base 24 of the frame 20 below at least a portion of the production line; placing the base 24 of the frame 20 directly on the ground; and / or arranging the optical scanner 22 adjacent to the predetermined inspection location, including, for example, above (for example, directly vertically above) the predetermined inspection location and / or horizontally offset to the side of the predetermined inspection location.
[0074] Once the system 10 is installed and configured, the processing subsystem 22 of the system 10 may be operated to determine characteristic(s) of the product(s) on the production line at the predetermined inspection location. In embodiments where the processing subsystem 22 is configured for label presence verification, the method 100 may involve the processing subsystem 22 acquiring color data and / or other output from the color detector 36 (block 106 in Fig. 12) and / or analyzing the output from the color detector 36 to determine if the product(s) is / are located at the predetermined inspection location (block 108 in Fig. 12). In some embodiments, the mentioned analysis may include, for example, the processing subsystem 22 comparing the color(s) detected by the color detector 36 with reference color(s) stored in the memory 52 representing, for example, the actual color(s) of an outer surface and / or other portion of the product(s).
[0075] In response to a determination that the product(s) are not located at the predetermined inspection location, the method 100 may return to block 106 and, in at least some embodiments, continue acquiring and / or analyzing output from the color detector 36.
[0076] In response to a determination that the product(s) are located at the predetermined inspection location, the processing subsystem 22 may then proceed with activating the light source 70, acquiring image data and / other output from the camera 34 (block 112 in Fig. 12), and / or analyzing the image data and / or other output from the camera 34 to determine, for example, the presence of label(s) on the product(s) at the predetermined inspection location and / or other characteristic(s) of the product(s) at the predetermined inspection location (block 114 in Fig. 12). In some embodiments, the mentioned analysis may include, for example, the processing subsystem 22 comparing image(s) captured by the camera 34 of the product(s) at the predetermined inspection location with the reference image(s) stored in the memory 52 to determine the presence of label(s) on the product(s) at the predetermined inspection location and / or other characteristic(s) of the product(s) at the predetermined inspection location. Additionally or alternatively, this step may include the processing subsystem 22 feeding the image(s) captured by the camera 34 of the product(s) at the predetermined inspect location to a neural network to determine the presence of label(s) on the product(s) at the predetermined inspection location and / or other characteristic(s) of the product(s) at the predetermined inspection location.
[0077] In response to a determination that the label(s) and / or other characteristic(s) are present on the inspected product(s), the method 100 may then check if there is another product to inspect (block 120 in Fig. 12). If not, the method 100 may end in some embodiments (block 122 in Fig. 12). Otherwise, the method 100 may return to block 106 and, in at least some embodiments, continue acquiring and / or analyzing output from the color detector 36.
[0078] In response to a determination that the label(s) and / or other characteristic(s) are absent from the inspected product(s), the processing subsystem 22 may then output a signal (for example a control signal) for stopping or slowing operation of the conveyor 16 and / or another portion of the production line 14, including, for example, outputting a signal for activating the stop11024-WC01-SEC mechanism 40 as seen in block 124. Additionally or alternatively, at block 124, the processing subsystem 22 may output a signal for activating an alarm for notifying an operator, worker, and / or other individual working on the production line 14 of the missing or misplaced label(s), including, for example, outputting a signal to the user interface 38 to cause it generate an audio and / or visual alarm. Once the missing or misplaced label(s) has / have been replaced by an operator and / or a machine (block 126 in Fig. 12), or once the product(s) with missing or misplaced label(s) have been removed from the production line by an operator and / or a machine, the production line may be restarted (block 128 in Fig. 12), and the method 100 may return to block 106 and, in at least some embodiments, continue acquiring and / or analyzing output from the color detector 36.
[0079] All features described herein, including in the specification, claims, abstract, and drawings, and all the steps in any method or process described herein, may be combined in any combination, except combinations where one or more of the features and / or steps are mutually exclusive.
[0080] As will be recognized, the systems and methods according to the present disclosure may have one or more advantages relative to conventional technology, any one or more of which may be present in a particular embodiment in accordance with the features of the present disclosure included in that embodiment. Other advantages not specifically listed herein may also be recognized as well.
[0081] The above description describes various devices, assemblies, components, subsystems and methods for use related to a drug delivery device. The devices, assemblies, components, subsystems, methods or drug delivery devices can further comprise or be used with a drug including but not limited to those drugs identified below as well as their generic and biosimilar counterparts. The term drug, as used herein, can be used interchangeably with other similar terms and can be used to refer to any type of medicament or therapeutic material including traditional and non-traditional pharmaceuticals, nutraceuticals, supplements, biologies, biologically active agents and compositions, large molecules, biosimilars, bioequivalents, therapeutic antibodies, polypeptides, proteins, small molecules and generics. Non-therapeutic injectable materials are also encompassed. The drug may be in liquid form, a lyophilized form, or in a reconstituted from lyophilized form. The following example list of drugs should not be considered as all-inclusive or limiting.
[0082] The drug will be contained in a reservoir. In some instances, the reservoir is a primary container that is either filled or pre-filled for treatment with the drug. The primary container can be a vial, a cartridge or a pre-filled syringe.
[0083] In some embodiments, the reservoir of the drug delivery device may be filled with or the device can be used with colony stimulating factors, such as granulocyte colony-stimulating factor (G-CSF). Such G-CSF agents include but are not limited to Neulasta® (pegfilgrastim, pegylated filgastrim , pegylated G-CSF, pegylated hu-Met-G-CSF) and Neupogen® (filgrastim, G-CSF, hu-MetG-CSF), UDENYCA® (pegfilgrastim-cbqv), Ziextenzo® (LA-EP2006; pegfilgrastim-bmez), or FULPHILA (pegfilgrastim-bmez).
[0084] In other embodiments, the drug delivery device may contain or be used with an erythropoiesis stimulating agent (ESA), which may be in liquid or lyophilized form. An ESA is any molecule that stimulates erythropoiesis. In some embodiments, an ESA is an erythropoiesis stimulating protein. As used herein, “erythropoiesis stimulating protein” means any protein that directly or indirectly causes activation of the erythropoietin receptor, for example, by binding to and causing dimerization of the receptor. Erythropoiesis stimulating proteins include erythropoietin and variants, analogs, or derivatives thereof that bind to and activate erythropoietin receptor; antibodies that bind to erythropoietin receptor and activate the receptor; or peptides that bind to and activate erythropoietin receptor. Erythropoiesis stimulating proteins include, but are not limited to, Epogen® (epoetin alfa), Aranesp® (darbepoetin alfa), Dynepo® (epoetin delta), Mircera® (methyoxy polyethylene glycol-epoetin beta), Hematide®, MRK-2578, INS-22, Retacrit® (epoetin zeta), Neorecormon® (epoetin beta), Silapo® (epoetin zeta), Binocrit® (epoetin alfa), epoetin alfa Hexal, Abseamed® (epoetin alfa), Ratioepo® (epoetin theta), Eporatio® (epoetin theta), Biopoin® (epoetin theta), epoetin alfa, epoetin beta, epoetin iota, epoetin omega, epoetin delta, epoetin zeta, epoetin theta, and epoetin delta, pegylated erythropoietin, carbamylated erythropoietin, as well as the molecules or variants or analogs thereof.11024-W001-SEC
[0085] Among particular illustrative proteins are the specific proteins set forth below, including fusions, fragments, analogs, variants or derivatives thereof: OPGL specific antibodies, peptibodies, related proteins, and the like (also referred to as RANKL specific antibodies, peptibodies and the like), including fully humanized and human OPGL specific antibodies, particularly fully humanized monoclonal antibodies; Myostatin binding proteins, peptibodies, related proteins, and the like, including myostatin specific peptibodies; IL-4 receptor specific antibodies, peptibodies, related proteins, and the like, particularly those that inhibit activities mediated by binding of IL-4 and / or IL-13 to the receptor; Interleukin 1-receptor 1 (“IL1-R1”) specific antibodies, peptibodies, related proteins, and the like; Ang2 specific antibodies, peptibodies, related proteins, and the like; NGF specific antibodies, peptibodies, related proteins, and the like; CD22 specific antibodies, peptibodies, related proteins, and the like, particularly human CD22 specific antibodies, such as but not limited to humanized and fully human antibodies, including but not limited to humanized and fully human monoclonal antibodies, particularly including but not limited to human CD22 specific IgG antibodies, such as, a dimer of a human-mouse monoclonal h LL2 gamma-chain disulfide linked to a human-mouse monoclonal h LL2 kappa-chain, for example, the human CD22 specific fully humanized antibody in Epratuzumab, CAS registry number 501423-23-0; IGF-1 receptor specific antibodies, peptibodies, and related proteins, and the like including but not limited to anti-IGF-1R antibodies; B-7 related protein 1 specific antibodies, peptibodies, related proteins and the like (“B7RP-1” and also referring to B7H2, ICOSL, B7h, and CD275), including but not limited to B7RP-specific fully human monoclonal I gG2 antibodies, including but not limited to fully human I gG2 monoclonal antibody that binds an epitope in the first immunoglobulin-like domain of B7RP-1, including but not limited to those that inhibit the interaction of B7RP-1 with its natural receptor, ICOS, on activated T cells; IL-15 specific antibodies, peptibodies, related proteins, and the like, such as, in particular, humanized monoclonal antibodies, including but not limited to HuMax IL-15 antibodies and related proteins, such as, for instance, 145c7; IFN gamma specific antibodies, peptibodies, related proteins and the like, including but not limited to human IFN gamma specific antibodies, and including but not limited to fully human anti-IFN gamma antibodies; TALL-1 specific antibodies, peptibodies, related proteins, and the like, and other TALL specific binding proteins; Parathyroid hormone (“PTH”) specific antibodies, peptibodies, related proteins, and the like; Thrombopoietin receptor (“TPO-R”) specific antibodies, peptibodies, related proteins, and the like; Hepatocyte growth factor (“HGF”) specific antibodies, peptibodies, related proteins, and the like, including those that target the HGF / SF:cMet axis (HGF / SF:c-Met), such as fully human monoclonal antibodies that neutralize hepatocyte growth factor / scatter (HGF / SF); TRAIL-R2 specific antibodies, peptibodies, related proteins and the like; Activin A specific antibodies, peptibodies, proteins, and the like; TGF-beta specific antibodies, peptibodies, related proteins, and the like; Amyloid-beta protein specific antibodies, peptibodies, related proteins, and the like; c-Kit specific antibodies, peptibodies, related proteins, and the like, including but not limited to proteins that bind c-Kit and / or other stem cell factor receptors; OX40L specific antibodies, peptibodies, related proteins, and the like, including but not limited to proteins that bind OX40L and / or other ligands of the 0X40 receptor; Activase® (alteplase, tPA); Aranesp® (darbepoetin alfa) Erythropoietin [30-asparagine, 32-threonine, 87-valine, 88-asparagine, 90-threonine], Darbepoetin alfa, novel erythropoiesis stimulating protein (NESP); Epogen® (epoetin alfa, or erythropoietin); GLP-1, Avonex® (interferon beta-1 a); Bexxar® (tositumomab, anti-CD22 monoclonal antibody); Betaseron® (interferon-beta);Campath® (alemtuzumab, anti-CD52 monoclonal antibody); Dynepo® (epoetin delta); Velcade® (bortezomib); MLN0002 (anti-a4B7 mAb); MLN1202 (anti-CCR2 chemokine receptor mAb); Enbrel® (etanercept, TNF-receptor / Fc fusion protein, TNF blocker); Eprex® (epoetin alfa); Erbitux® (cetuximab, anti-EGFR / HER1 / c-ErbB-1); Genotropin® (somatropin, Human Growth Hormone); Herceptin® (trastuzumab, anti-HER2 / neu (erbB2) receptor mAb); Kanjinti ™ (trastuzumab-anns) anti-HER2 monoclonal antibody, biosimilar to Herceptin®, or another product containing trastuzumab for the treatment of breast or gastric cancers; Humatrope® (somatropin, Human Growth Hormone); Humira® (adalimumab); Vectibix® (panitumumab), Xgeva® (denosumab), Prolia® (denosumab), Immunoglobulin G2 Human Monoclonal Antibody to RANK Ligand, Enbrel® (etanercept, TNF-receptor / Fc fusion protein, TNF blocker), Nplate® (romiplostim), rilotumumab, ganitumab, conatumumab, brodalumab, insulin in solution; Infergen® (interferon alfacon-1); Natrecor® (nesiritide; recombinant human B-type natriuretic peptide (hBNP);11024-W001-SEC Kineret® (anakinra); Leukine® (sargamostim, rhuGM-CSF); LymphoCide® (epratuzumab, anti-CD22 mAb); Benlysta™ (lymphostat B, belimumab, anti-BlyS mAb); Metalyse® (tenecteplase, t-PA analog); Mircera® (methoxy polyethylene glycol-epoetin beta); Mylotarg® (gemtuzumab ozogamicin); Raptiva® (efalizumab); Cimzia® (certolizumab pegol, CDP 870); Soliris™ (eculizumab); pexelizumab (anti-C5 complement); Numax® (MEDI-524); Lucentis® (ranibizumab); Panorex® (17-1A, edrecolomab); Trabio® (lerdelimumab); TheraCim hR3 (nimotuzumab); Omnitarg (pertuzumab, 2C4); Osidem® (IDM-1);OvaRex® (B43.13); Nuvion® (visilizumab); cantuzumab mertansine (huC242-DM1); NeoRecormon® (epoetin beta); Neumega® (oprelvekin, human interleukin-11); Orthoclone OKT3® (muromonab-CD3, anti-CD3 monoclonal antibody); Procrit® (epoetin alfa); Remicade® (infliximab, anti-TNFa monoclonal antibody); Reopro® (abciximab, anti-GP llb / llia receptor monoclonal antibody); Actemra® (anti-l L6 Receptor mAb); Avastin® (bevacizumab), HuMax-CD4 (zanolimumab); MvasiTM (bevacizumab-awwb); Rituxan® (rituximab, anti-CD20 mAb); Tarceva® (erlotinib); Roferon-A®-(interferon alfa-2a); Simulect® (basiliximab); Prexige® (lumiracoxib); Synagis® (palivizumab); 145c7-CHO (anti-l L15 antibody, see U.S. Patent No. 7,153,507); Tysabri® (natalizumab, anti-a4integrin mAb); Valortim® (MDX-1303, anti-B. anthracis protective antigen mAb); ABthrax™; Xolair® (omalizumab); ETI211 (anti-MRSA mAb); IL-1 trap (the Fc portion of human I gG 1 and the extracellular domains of both IL-1 receptor components (the Type I receptor and receptor accessory protein)); VEGF trap (Ig domains of VEGFR1 fused to I gG 1 Fc); Zenapax® (daclizumab); Zenapax® (daclizumab, anti-l L-2Ra mAb); Zevalin® (ibritumomab tiuxetan); Zetia® (ezetimibe); Orencia® (atacicept, TACI-lg); anti-CD80 monoclonal antibody (galiximab); anti-CD23 mAb (lumiliximab); BR2-Fc (huBR3 / huFc fusion protein, soluble BAFF antagonist); ONTO 148 (golimumab, anti-TNFa mAb); HGS-ETR1 (mapatumumab; human anti-TRAIL Receptor-1 mAb); HuMax-CD20 (ocrelizumab, anti-CD20 human mAb); HuMax-EGFR (zalutumumab); M200 (volociximab, anti-a5 1 integrin mAb); MDX-010 (ipilimumab, anti-CTLA-4 mAb and VEGFR-1 (IMC-18F1); anti-BR3 mAb; anti-C. difficile Toxin A and Toxin B C mAbs MDX-066 (CDA-1) and MDX-1388); anti-CD22 dsFv-PE38 conjugates (CAT-3888 and CAT-8015); anti-CD25 mAb (HuMax-TAC); anti-CD3 mAb (NI-0401); adecatumumab; anti-CD30 mAb (MDX-060); MDX-1333 (anti-IFNAR); anti-CD38 mAb (HuMax CD38); anti-CD40L mAb; anti-Cripto mAb; anti-CTGF Idiopathic Pulmonary Fibrosis Phase I Fibrogen (FG-3019); anti-CTLA4 mAb; anti-eotaxin1 mAb (CAT-213); anti-FGF8 mAb; anti-ganglioside GD2 mAb; antiganglioside GM2 mAb; anti-GDF-8 human mAb (MYO-029); anti-GM-CSF Receptor mAb (CAM-3001); anti-HepC mAb (HuMax HepC); anti-l FNa mAb (MEDI-545, MDX-198); anti-IGF1R mAb; anti-IGF-1 R mAb (HuMax-Inflam); anti-IL12 mAb (ABT-874); anti-IL12 / IL23 mAb (CNTO 1275); anti-l L13 mAb (CAT-354); anti-IL2Ra mAb (HuMax-TAC); anti-IL5 Receptor mAb; anti-integrin receptors mAb (MDX-018, CNTO 95); anti-IP10 Ulcerative Colitis mAb (MDX-1100); BMS-66513; anti-Mannose Receptor / hCGfJ mAb (MDX-1307); anti-mesothelin dsFv-PE38 conjugate (CAT-5001); anti-PD1mAb (MDX-1106 (ONO-4538)); anti-PDGFRa antibody (IMC-3G3); anti-TGFB mAb (GC-1008); anti-TRAIL Receptor-2 human mAb (HGS-ETR2); anti-TWEAK mAb; anti-VEGFR / Flt-1 mAb; and anti-ZP3 mAb (HuMax-ZP3).
[0086] In some embodiments, the drug delivery device may contain or be used with a sclerostin antibody, such as but not limited to romosozumab, blosozumab, BPS 804 (Novartis), Evenity™ (romosozumab-aqqg), another product containing romosozumab for treatment of postmenopausal osteoporosis and / or fracture healing and in other embodiments, a monoclonal antibody (I gG) that binds human Proprotein Convertase Subtilisin / Kexin Type 9 (PCSK9). Such PCSK9 specific antibodies include, but are not limited to, Repatha® (evolocumab) and Praluent® (alirocumab). In other embodiments, the drug delivery device may contain or be used with rilotumumab, bixalomer, trebananib, ganitumab, conatumumab, motesanib diphosphate, brodalumab, vidupiprant or panitumumab. In some embodiments, the reservoir of the drug delivery device may be filled with or the device can be used with IMLYGIC® (talimogene laherparepvec) or another oncolytic HSV for the treatment of melanoma or other cancers including but are not limited to OncoVEXGALV / CD; OrienXOW; G207, 1716; NV1020; NV12023; NV1034; and NV1042. In some embodiments, the drug delivery device may contain or be used with endogenous tissue inhibitors of metalloproteinases (TIMPs) such as but not limited to TIMP-3. In some embodiments, the drug delivery device may contain or be used with Aimovig® (erenumab-aooe), anti-human CGRP-R (calcitonin gene-related peptide type 1 receptor) or another product11024-WC01-SEC containing erenumab for the treatment of migraine headaches. Antagonistic antibodies for human calcitonin gene-related peptide (CGRP) receptor such as but not limited to erenumab and bispecific antibody molecules that target the CGRP receptor and other headache targets may also be delivered with a drug delivery device of the present disclosure. Additionally, bispecific T cell engager (BITE®) molecules such as but not limited to BLINCYTO® (blinatumomab) can be used in or with the drug delivery device of the present disclosure. In some embodiments, the drug delivery device may contain or be used with an APJ large molecule agonist such as but not limited to apelin or analogues thereof. In some embodiments, a therapeutically effective amount of an anti-thymic stromal lymphopoietin (TSLP) or TSLP receptor antibody is used in or with the drug delivery device of the present disclosure. In some embodiments, the drug delivery device may contain or be used with AvsolaTM (infliximab-axxq), anti-TNF a monoclonal antibody, biosimilar to Remicade® (infliximab) (Janssen Biotech, Inc.) or another product containing infliximab for the treatment of autoimmune diseases. In some embodiments, the drug delivery device may contain or be used with Kyprolis® (carfilzomib), (2S)-N-((S)-1-((S)-4-methyl-1-((R)-2-methyloxiran-2-yl)-1-oxopentan-2-ylcarbamoyl)-2-phenylethyl)-2-((S)-2-(2-morpholinoacetamido)-4-phenylbutanamido)-4-methylpentanamide, or another product containing carfilzomib for the treatment of multiple myeloma. In some embodiments, the drug delivery device may contain or be used with Otezla® (apremilast), N-[2-[(1 S)-1-(3-ethoxy-4-methoxyphenyl)-2-(methylsulfonyl)ethyl]-2,3-dihydro-1 ,3-dioxo- 1 H-isoindol-4-yl]acetamide, or another product containing apremilast for the treatment of various inflammatory diseases. In some embodiments, the drug delivery device may contain or be used with ParsabivTM (etelcalcetide HCI, KAI-4169) or another product containing etelcalcetide HCI for the treatment of secondary hyperparathyroidism (sHPT) such as in patients with chronic kidney disease (KD) on hemodialysis. In some embodiments, the drug delivery device may contain or be used with ABP 798 (rituximab), a biosimilar candidate to Rituxan® / MabThera™, or another product containing an anti-CD20 monoclonal antibody. In some embodiments, the drug delivery device may contain or be used with a VEGF antagonist such as a non-antibody VEGF antagonist and / or a VEGF-Trap such as aflibercept (Ig domain 2 from VEGFR1 and Ig domain 3 from VEGFR2, fused to Fc domain of I gG 1 ) . In some embodiments, the drug delivery device may contain or be used with ABP 959 (eculizumab), a biosimilar candidate to Soliris®, or another product containing a monoclonal antibody that specifically binds to the complement protein C5. In some embodiments, the drug delivery device may contain or be used with Rozibafusp alfa (formerly AMG 570) is a novel bispecific antibody-peptide conjugate that simultaneously blocks ICOSL and BAFF activity. In some embodiments, the drug delivery device may contain or be used with Omecamtiv mecarbil, a small molecule selective cardiac myosin activator, or myotrope, which directly targets the contractile mechanisms of the heart, or another product containing a small molecule selective cardiac myosin activator. In some embodiments, the drug delivery device may contain or be used with Sotorasib (formerly known as AMG 510), a KRASG12C small molecule inhibitor, or another product containing a KRASG12C small molecule inhibitor. In some embodiments, the drug delivery device may contain or be used with Tezepelumab, a human monoclonal antibody that inhibits the action of thymic stromal lymphopoietin (TSLP), or another product containing a human monoclonal antibody that inhibits the action of TSLP. In some embodiments, the drug delivery device may contain or be used with AMG 714, a human monoclonal antibody that binds to Interleukin-15 (IL-15) or another product containing a human monoclonal antibody that binds to Interleukin-15 (IL-15). In some embodiments, the drug delivery device may contain or be used with AMG 890, a small interfering RNA (siRNA) that lowers lipoprotein(a), also known as Lp(a), or another product containing a small interfering RNA (siRNA) that lowers lipoprotein(a). In some embodiments, the drug delivery device may contain or be used with ABP 654 (human IgG 1 kappa antibody), a biosimilar candidate to Stelara®, or another product that contains human IgG 1 kappa antibody and / or binds to the p40 subunit of human cytokines interleukin (I L)-12 and IL-23. In some embodiments, the drug delivery device may contain or be used with AmjevitaTM or AmgevitaTM (formerly ABP 501) (mab anti-TNF human lgG1), a biosimilar candidate to Humira®, or another product that contains human mab anti-TNF human lgG1. In some embodiments, the drug delivery device may contain or be used with AMG 160, or another product that contains a half-life extended (HLE) anti-prostate-specific membrane antigen (PSMA) x anti-CD3 BiTE® (bispecific T cell engager) construct. In some embodiments, the11024-W001-SEC drug delivery device may contain or be used with AMG 119, or another product containing a delta-like ligand 3 (DLL3) CAR T (chimeric antigen receptor T cell) cellular therapy. In some embodiments, the drug delivery device may contain or be used with AMG 119, or another product containing a delta-like ligand 3 (DLL3) CAR T (chimeric antigen receptor T cell) cellular therapy. In some embodiments, the drug delivery device may contain or be used with AMG 133, or another product containing a gastric inhibitory polypeptide receptor (GIPR) antagonist and GLP-1R agonist. In some embodiments, the drug delivery device may contain or be used with AMG 171 or another product containing a Growth Differential Factor 15 (GDF15) analog. In some embodiments, the drug delivery device may contain or be used with AMG 176 or another product containing a small molecule inhibitor of myeloid cell leukemia 1 (MCL-1). In some embodiments, the drug delivery device may contain or be used with AMG 199 or another product containing a half-life extended (HLE) bispecific T cell engager construct (BITE®). In some embodiments, the drug delivery device may contain or be used with AMG 256 or another product containing an anti-PD-1 x IL21 mutein and / or an IL-21 receptor agonist designed to selectively turn on the Interleukin 21 (IL-21) pathway in programmed cell death-1 (PD-1) positive cells. In some embodiments, the drug delivery device may contain or be used with AMG 330 or another product containing an anti-CD33 x anti-CD3 BiTE® (bispecific T cell engager) construct. In some embodiments, the drug delivery device may contain or be used with AMG 404 or another product containing a human anti-programmed cell death-1 (PD-1) monoclonal antibody being investigated as a treatment for patients with solid tumors. In some embodiments, the drug delivery device may contain or be used with AMG 427 or another product containing a half-life extended (HLE) anti-fms-like tyrosine kinase 3 (FLT3) x anti-CD3 BiTE® (bispecific T cell engager) construct. In some embodiments, the drug delivery device may contain or be used with AMG 430 or another product containing an anti-Jagged-1 monoclonal antibody. In some embodiments, the drug delivery device may contain or be used with AMG 506 or another product containing a multi-specific FAP x 4-1 BB-targeting DARPin® biologic under investigation as a treatment for solid tumors. In some embodiments, the drug delivery device may contain or be used with AMG 509 or another product containing a bivalent T-cell engager and is designed using XmAb® 2+1 technology. In some embodiments, the drug delivery device may contain or be used with AMG 562 or another product containing a half-life extended (HLE) CD19 x CD3 BiTE® (bispecific T cell engager) construct. In some embodiments, the drug delivery device may contain or be used with Efavaleukin alfa (formerly AMG 592) or another product containing an IL-2 mutein Fc fusion protein. In some embodiments, the drug delivery device may contain or be used with AMG 596 or another product containing a CD3 x epidermal growth factor receptor vl 11 (EGFRvlll) BiTE® (bispecific T cell engager) molecule. In some embodiments, the drug delivery device may contain or be used with AMG 673 or another product containing a half-life extended (HLE) anti-CD33 x anti-CD3 BiTE® (bispecific T cell engager) construct. In some embodiments, the drug delivery device may contain or be used with AMG 701 or another product containing a half-life extended (HLE) anti-B-cell maturation antigen (BCMA) x anti-CD3 BiTE® (bispecific T cell engager) construct. In some embodiments, the drug delivery device may contain or be used with AMG 757 or another product containing a half-life extended (HLE) anti- delta-like ligand 3 (DLL3) x anti-CD3 BiTE® (bispecific T cell engager) construct. In some embodiments, the drug delivery device may contain or be used with AMG 910 or another product containing a half-life extended (HLE) epithelial cell tight junction protein claudin 18.2 x CD3 BiTE® (bispecific T cell engager) construct.
[0087] Although the drug delivery devices, assemblies, components, subsystems and methods have been described in terms of exemplary embodiments, they are not limited thereto. The detailed description is to be construed as exemplary only and does not describe every possible embodiment of the present disclosure. Numerous alternative embodiments could be implemented, using either current technology or technology developed after the filing date of this patent that would still fall within the scope of the claims defining the invention(s) disclosed herein.
[0088] Those skilled in the art will recognize that a wide variety of modifications, alterations, and combinations can be made with respect to the above described embodiments without departing from the spirit and scope of the invention(s) disclosed herein, and that such modifications, alterations, and combinations are to be viewed as being within the ambit of the inventive concept(s).
Claims
11024-W001-SEC What is claimed is:
1. A system for inspecting one or more products on a production line, the system comprising:an optical scanner configured to scan at least one product of the one or more products on the production line at a predetermined inspection location; anda frame separate from the production line and configured to support the optical scanner adjacent to the predetermined inspection location, the frame comprising:a base, anda vertical support extending upwardly from the base and configured to support the optical scanner adjacent to the predetermined inspection location.
2. The system of claim 1, wherein the frame is configured for installation adjacent to the production line without structurally modifying the production line.
3. The system of any of claims 1 or 2, wherein the frame is configured for installation adjacent to the production line without mechanically coupling with the production line.
4. The system of any one of claims 1 to 3, wherein the frame is configured for installation adjacent to the production line without relying on the production line for mechanical support.
5. The system of any one of claims 1 to 4, wherein the frame is a freestanding structure.
6. The system of any one of claims 1 to 5, wherein at least a portion of the base is configured for placement below at least a portion of the production line.
7. The system of any one of claims 1 to 6, wherein the base is configured to rest directly on the ground.
8. The system of any one of claims 1 to 7, wherein the frame is configured to support the optical scanner above the predetermined inspection location.
9. The system of any one of claims 1 to 8, wherein the frame comprises a first arm which extends horizontally or substantially horizontally from a top end of the vertical support and couples with the optical scanner.
10. The system of claim 9, wherein the frame comprises a second arm disposed below the first arm and extending horizontally or substantially from the vertical support.
11. The system of claim 10, wherein the first arm and the second arm are perpendicular or substantially perpendicular to each other.
12. The system of any one of claims 1 to 11, wherein the optical scanner comprises a camera.
13. The system of any one of claims 1 to 12, wherein the optical scanner comprises a color detector.11024-W001-SEC14. The system of any one of claims 1 to 13, comprising a processing subsystem configured to analyze output from the optical scanner to determine at least one characteristic of the at least one product on the production line.
15. The system of claim 14, wherein the at least one characteristic comprises a presence of at least one label on the at least one product on the production line.
16. The system of claim 15, wherein the processing subsystem is configured to output at least one signal for stopping or slowing operation of at least a portion of the production line in response to a determination that the at least one label is absent from the at least one product on the production line.
17. The system of any one of claims 15 or 16, wherein the processing subsystem is configured to output at least one signal for activating an alarm in response to a determination that the at least one label is absent from the at least one product on the production line.
18. The system of any one of claims 14 to 17, wherein the optical scanner comprises a camera and a color detector.
19. The system of claim 18, wherein the processing subsystem is configured to determine if the at least one product on the production line is located at the predetermined inspection location based on output from the color detector, and if the at least one product on the production line is located at the predetermined inspection location, analyzing at least one image captured by the camera of the at least one product on the production line.
20. The system of claim 19, wherein the processing subsystem is configured to compare the at least one image with one or more reference images stored in a memory to determine the at least one characteristic of the at least one product on the production line.
21. The system of any one of claims 1 to 20, wherein the frame is configured for installation at multiple selected locations along the production line.
22. The system of any one of claims 1 to 21, wherein the at least one product on the production line comprises a drug, a drug container, and / or a drug delivery device.
23. The system of claim 22, wherein the drug, the drug container, and / or the drug delivery device is disposed at least partially within packaging.
24. The system of any one of claims 18 to 20, comprising a light source configured to selectively illuminate the predetermined inspection location.
25. The system of claim 24, wherein the processing subsystem is configured to determine if the at least one product on the production line is located at the predetermined inspection location based on output from the color detector, and if the at least one product on the production line is located at the predetermined inspection location, activate the light source to illuminate the predetermined inspection location.11024-W001-SEC26. The system of any one of claims 24 or 25, wherein the light source comprises a central opening, and wherein the camera is disposed at least partially within the central opening and / or comprises an optical axis which passes through the central opening.
27. The system of claim 16, comprising a stop mechanism configured to stop movement of a conveyor of the production line in response to the at least one signal output by the processing subsystem.
28. The system of claim 27, wherein the stop mechanism comprises an actuator configured to block or clear a sensing field of a sensing element of the production line when the actuator is activated.
29. The system of claim 28, wherein the actuator comprises a pneumatic cylinder and a pressure sensor configured to detect a loss of air supply to the pneumatic cylinder.
30. The system of claim 29, wherein the stop mechanism is configured to output at least one signal for activating an alarm in response to the pressure sensor detecting a loss of air supply to the pneumatic cylinder.
31. A method comprising:configuring a system along a production line for inspecting one or more products on the production line, wherein the system comprises:an optical scanner configured to scan at least one product of the one or more products on the production line at a predetermined inspection location, anda frame separate from the production line and configured to support the optical scanner adjacent to the predetermined inspection location, wherein the frame comprises a base and a vertical support extending upwardly from the base, and wherein the vertical support is configured to support the optical scanner adjacent to the predetermined inspection location; and operating the system to determine at least one characteristic of the at least one product on the production line.
32. The method of claim 31, wherein configuring the system along the production line does not structurally modify the production line.
33. The method of any one of claims 31 or 32, wherein configuring the system along the production line does not comprise mechanically coupling the frame with the production line.
34. The method of any one of claims 31 to 33, wherein the frame does not rely on the production line for mechanical support once installed.
35. The method of any one of claims 31 to 34, wherein the frame is a freestanding structure.
36. The method of any one of claims 31 to 35, wherein configuring the system along the production line comprises arranging the base of the frame below at least a portion of the production line.11024-W001-SEC 37. The method of any one of claims 31 to 36, wherein configuring the system along the production line comprises placing the base directly on the ground.
38. The method of any one of claims 31 to 37, wherein configuring the system along the production line comprises arranging the optical scanner above the predetermined inspection location.
39. The method of any one of claims 31 to 38, wherein the frame comprises a first arm which extends horizontally or substantially horizontally from a top end of the vertical support and couples with the optical scanner.
40. The method of any one of claims 31 to 39, wherein configuring the system along the production line comprises installing the system at or immediately or substantially immediately upstream of a terminal workstation of the production line.
41. The method of any one of claims 31 to 40, wherein the optical scanner comprises a camera.
42. The method of any one of claims 31 to 41, wherein the optical scanner comprises a color detector.
43. The method of any one of claims 31 to 42, wherein operating the system to determine the at least one characteristic of the at least one product on the production line comprises a processing subsystem analyzing output from the optical scanner to determine the at least one characteristic of the at least one product on the production line.
44. The method of claim 43, wherein the at least one characteristic comprises a presence of at least one label on the at least one product on the production line.
45. The method of claim 44, comprising the processing subsystem outputting at least one signal for stopping or slowing operation of at least a portion of the production line in response to a determination that the at least one label is absent from the at least one product on the production line.
46. The method of any one of claims 44 or 45, comprising the processing subsystem outputting at least one signal for activating an alarm in response to a determination that the at least one label is absent from the at least one product on the production line.
47. The method of any one of claims 43 to 46, wherein the optical scanner comprises a camera and a color detector.
48. The method of claim 47, comprising the processing subsystem determining if the at least one product on the production line is located at the predetermined inspection location based on output from the color detector, and if the at least one product on the production line is located at the predetermined inspection location, analyzing at least one image captured by the camera of the at least one product on the production line.
49. The method of claim 48, comprising the processing subsystem comparing the at least one image with one or more reference images stored in a memory to determine the at least one characteristic of the at least one product on the production line.11024-W001-SEC 50. The method of any one of claims 31 to 49, wherein the at least one product on the production line comprises a drug, a drug container, and / or a drug delivery device.
51. The method of claim 50, wherein the drug, the drug container, and / or the drug delivery device is disposed at least partially within packaging.
52. The method of any one of claims 47 to 49, comprising the processing subsystem determining if the at least one product on the production line is located at the predetermined inspection location based on output from the color detector, and if the at least one product on the production line is located at the predetermined inspection location, activating a light source to illuminate the predetermined inspection location.