System and method for measuring the geometric dimensions of syringes and / or plunger stoppers

Abstract

A system and method for generating geometric dimensions of a syringe or plunger stopper are provided. The geometric dimensions may be based on at least one image of at least a part of the syringe or plunger stopper. A fixture for positioning the syringe or plunger stopper in close proximity to an associated imaging device is also provided.

Description

Technical Field

[0001] Cross - Reference to Related Applications Priority is claimed to U.S. Provisional Patent Application No. 63 / 453,340, filed on March 20, 2023, the entire content of which is incorporated herein by reference.

[0002] The present disclosure generally relates to measuring the geometric dimensions of a syringe and / or a plunger stopper, and more specifically, to measuring the geometric dimensions of a syringe and / or a plunger stopper based on a related digital image.

Background Art

[0003] Various pharmaceuticals are manufactured and stored in syringes. Related pre - filled syringes can be manufactured to high quality standards. Pre - filled syringes often include a plunger stopper that fits snugly within the barrel of the syringe. Some geometric dimensions of both the syringe (e.g., barrel inner diameter, luer outer diameter, dosing line position, flange diameter, barrel length, flange thickness, barrel outer diameter, etc.) and the plunger stopper (e.g., overall length, width, angular alignment, etc.) are tightly controlled.

[0004] The geometric dimensions of the syringe and the geometric dimensions of the plunger stopper are typically measured manually, for example, using a ruler, caliper, etc. Manually measuring the geometric dimensions of the syringe and the plunger stopper is time - consuming and subject to human error. The related records of geometric dimensions are also subject to error.

Summary of the Invention

Means for Solving the Problems

[0005] Embodiments described herein relate to a system and method for measuring the geometric dimensions of a syringe and / or a plunger stopper.

[0006] As described herein, a syringe fixture may be configured to align the central syringe axis of the syringe with the central image axis of the imaging system. The syringe fixture includes a support block defining a V-shaped notch, a first planar support surface, and a second planar support surface. The first planar support surface has a first edge. The second planar support surface has a second edge, at least a portion of which is coupled to at least a portion of which is coupled to the first edge, and the second planar support surface is perpendicular to the first planar support surface. The syringe fixture also includes a syringe fixing mechanism coupled to a support body and configured to fix the syringe in a fixed position within the V-shaped notch, thereby causing the syringe to take a first orientation when the support block is positioned on the first planar support surface and a second orientation perpendicular to the first orientation when the support block is positioned on the second planar support surface.

[0007] A system for measuring at least one geometric dimension of a syringe includes a syringe imaging system having a central imaging axis and a stage plane. The system also includes a syringe fixture configured to fix the syringe in a first orientation with respect to the central imaging axis when a support block is placed on a first planar support surface. The system further includes an image sensor fixed by the syringe fixture and configured to capture a first image of at least a portion of the syringe when it is placed on the first plane. The system further includes one or more processors configured to generate at least one geometric measurement of the syringe based on at least the first image.

[0008] A method for measuring the geometric dimensions of a syringe includes fixing the syringe to a syringe fixture. The method also includes positioning the syringe and syringe fixture at a first position on the stage plane of an imaging system, wherein the syringe has a central syringe axis that takes a first predetermined orientation with respect to the central image axis of the imaging system. The method further includes acquiring at least one image of at least a portion of the syringe using the image sensor of the imaging system. The method further includes calculating at least a first geometric dimension of the syringe based on at least one image using the processor of the imaging system.

[0009] A plunger stopper fixture may be configured to align the central plunger stopper axis of the plunger stopper with the central image axis of the imaging system. The plunger stopper fixture includes a base which includes an imaging system mount configured to be fixed in a fixed position with respect to the stage of the imaging system which has a central image axis. The plunger stopper fixture includes a plunger stopper rotation mechanism coupled to the base which includes a dial which is rotatable about a dial axis and a rod which extends from the dial along the dial axis. The rod has a distal end which is positioned away from the dial. The distal end of the rod has a plunger stopper retaining tip which is configured to fix the plunger stopper to the plunger stopper fixture and to align with the central image axis. The plunger stopper rotation mechanism is configured such that the central plunger stopper axis of the plunger stopper is aligned coaxially with the dial axis, and when the dial rotates about the dial axis, the plunger stopper rotates about the central plunger stopper axis.

[0010] A system for measuring at least one geometric dimension of a plunger stopper includes a plunger stopper imaging device having a central imaging axis. The system also includes a plunger stopper fixture having a plunger stopper rotation mechanism, the plunger stopper fixture being configured to fix the plunger stopper relative to the plunger stopper imaging device with the central plunger stopper axis aligned with the central image axis, the plunger stopper rotation mechanism being configured to rotate the plunger stopper about the central plunger stopper axis, the plunger stopper imaging device capturing a first image of at least a portion of the plunger stopper with the plunger stopper oriented at a first rotation angle around the central plunger stopper axis, and capturing a second image of at least a portion of the plunger stopper with the plunger stopper oriented at a second rotation angle around the central plunger stopper axis. The system further includes a geometric measurement generation device configured to generate at least one geometric measurement of the plunger stopper based on the first and second images.

[0011] A method for measuring at least one geometric dimension of a plunger stopper includes aligning the central plunger stopper axis of the plunger stopper at a fixed angle with respect to the central image axis of an imaging device and at an initial rotation angle around the central plunger stopper axis. The method also includes capturing a first image of the plunger stopper's profile diagram using an imager with the plunger stopper oriented at the initial rotation angle around the central plunger stopper axis. The method further includes determining a first value of at least one geometric dimension of the plunger stopper based on the first image using a processor. The method further includes rotating the plunger stopper to a second rotation angle around the central plunger stopper axis. The method also includes capturing a second image of the plunger stopper's profile diagram using an imager with the plunger stopper oriented at a second rotation angle. The method further includes determining a second value of at least one geometric dimension of the plunger stopper based on the second image using a processor.

[0012] A novel system and method are provided for measuring the geometric dimensions of syringes and / or plunger stoppers.

[0013] Those skilled in the art will understand that the drawings described herein are included for illustrative purposes only and do not limit the disclosure. The drawings are not necessarily to scale and instead focus on illustrating the principles of the disclosure. In some cases, various aspects of the embodiments described may be exaggerated or enlarged to facilitate understanding of the embodiments described. In the drawings, similar reference numerals throughout the various drawings refer to components that are generally functionally and / or structurally similar. [Brief explanation of the drawing]

[0014] [Figure 1A] An exemplary syringe measurement system is shown. [Figure 1B] An exemplary syringe measurement system is shown. [Figure 2] An exemplary user interface display is shown. [Figure 3] An exemplary syringe fixture is shown, which includes a syringe having a central syringe axis parallel to the central image axis. [Figure 4] An exemplary syringe fixture is shown, which includes a syringe having a central syringe axis perpendicular to the central image axis. [Figure 5] An exemplary syringe fixture is shown, which includes a syringe having a central syringe axis parallel to the central image axis. [Figure 6] An exemplary syringe fixture is shown, comprising a syringe with a central syringe axis parallel to the central image axis for measuring barrel ID. [Figure 7] This shows an exemplary user interface display for a syringe fixture equipped with a syringe having a central syringe axis parallel to the central image axis. [Figure 8]An exemplary syringe jig is shown that includes a syringe having a central syringe axis parallel to the central image axis and proximate to the optical probe. [Figure 9] An exemplary user interface display of a syringe jig that includes a syringe having a central syringe axis parallel to the central image axis is shown. [Figure 10] An exemplary syringe jig is shown that includes a syringe having a central syringe axis perpendicular to the central image axis for measuring the luer OD. [Figure 11] An exemplary user interface display of a syringe jig that includes a syringe having a central syringe axis parallel to the central image axis is shown. [Figure 12] An exemplary user interface display of a syringe jig that includes a syringe having a central syringe axis parallel to the central image axis is shown. [Figure 13] An exemplary user interface display of a syringe jig that includes a syringe having a central syringe axis perpendicular to the central image axis for measuring the administration line position is shown. [Figure 14] An exemplary user interface display of a syringe jig that includes a syringe having a central syringe axis perpendicular to the central image axis is shown. [Figure 15] An exemplary syringe jig is shown that includes a syringe having a central syringe axis parallel to the central image axis. [Figure 16] An exemplary syringe jig is shown that includes a syringe having a central syringe axis parallel to the central image axis and the orientation of the syringe flange. [Figure 17] An exemplary user interface display of a syringe jig that includes a syringe having a central syringe axis parallel to the central image axis and the syringe flange diameter is shown. [Figure 18] An exemplary user interface display of a syringe jig that includes a syringe having a central syringe axis parallel to the central image axis and the syringe flange diameter is shown. [Figure 19] An exemplary syringe jig is shown that includes a syringe having a central syringe axis perpendicular to the central image axis for measuring the syringe barrel length. [Figure 20] An exemplary user interface display of a syringe jig with a syringe having a central syringe axis perpendicular to a central image axis for syringe barrel length measurement is shown. [Figure 21] An exemplary user interface display of a syringe jig with a syringe having a central syringe axis perpendicular to a central image axis for syringe barrel length measurement is shown. [Figure 22] An exemplary syringe jig with a syringe having a central syringe axis perpendicular to a central image axis for syringe flange thickness measurement is shown. [Figure 23] An exemplary user interface display of a syringe jig with a syringe having a central syringe axis perpendicular to a central image axis for syringe flange thickness measurement is shown. [Figure 24] An exemplary user interface display of a syringe jig with a syringe having a central syringe axis perpendicular to a central image axis for syringe barrel OD measurement is shown. [Figure 25] An exemplary user interface display of a syringe jig with a syringe having a central syringe axis perpendicular to a central image axis for syringe barrel OD measurement is shown. [Figure 26A] An exemplary method of measuring geometric dimensions of a syringe. [Figure 26B] An exemplary method of measuring geometric dimensions of a syringe. [Figure 26C] An exemplary method of measuring geometric dimensions of a syringe. [Figure 26D] An exemplary method of measuring geometric dimensions of a syringe. [Figure 26E] An exemplary method of measuring geometric dimensions of a syringe. [Figure 26F] An exemplary method of measuring geometric dimensions of a syringe. [Figure 26G] An exemplary method of measuring geometric dimensions of a syringe. [Figure 27] An exemplary plunger stopper measurement system is shown. [Figure 28] An exemplary plunger stopper measurement system with a plunger stopper fixture is shown. [Figure 29] An exemplary plunger stopper measurement system is shown, comprising a plunger stopper fixture and a plunger stopper having a central plunger stopper axis perpendicular to the central image axis. [Figure 30] This shows an exemplary user interface display for a plunger stopper fixture equipped with a plunger stopper having a central plunger stopper axis perpendicular to the central image axis. [Figure 31] This shows the dial indicator of the plunger stopper jig, which has been reoriented from 90° to 70°. [Figure 32] This shows an exemplary user interface display for a plunger stopper fixture equipped with a plunger stopper having a central plunger stopper axis perpendicular to the central image axis. [Figure 33] This shows an exemplary user interface display for a plunger stopper fixture equipped with a plunger stopper having a central plunger stopper axis perpendicular to the central image axis. [Figure 34] This shows an exemplary user interface display for a plunger stopper fixture equipped with a plunger stopper having a central plunger stopper axis perpendicular to the central image axis. [Figure 35] This document illustrates an exemplary method for measuring the geometric dimensions of a plunger stopper. [Modes for carrying out the invention]

[0015] Those skilled in the art will understand that elements in the drawings are depicted for simplification and clarity and are not necessarily drawn to a specific scale. For example, the dimensions and / or relative positions of some elements in the drawings may be exaggerated relative to others to help improve the understanding of the various embodiments of the invention. Also, common but well-understood elements that are useful or necessary in commercially viable embodiments are often omitted so as not to interfere too much with the drawings of these various embodiments. Furthermore, it will be recognized that certain actions and / or processes may be described or shown in a specific order of occurrence, but those skilled in the art will understand that such specificity regarding order is not actually necessary. It will also be understood that the terms and expressions used herein have the ordinary technical meanings that those skilled in the art would give to such terms and expressions, as described above, unless a different specific meaning is explained herein.

[0016] The various concepts introduced above and examined in more detail below may be implemented using any of many methods, and the concepts described are not limited to any particular implementation method. Examples of implementations are provided for illustrative purposes.

[0017] A system and method are provided for measuring the geometric dimensions of syringes (e.g., barrel inner diameter, Luer outer diameter, dosing line position, flange diameter, barrel length, flange thickness, barrel outer diameter, etc.) and plunger stoppers (e.g., overall length, width, angular alignment, etc.). A syringe fixture is provided for aligning the central syringe axis with the central image axis of the associated imaging device. The geometric dimensions of the syringe are measured based on one or more images and / or optical probe measurements of the syringe. A plunger stopper fixture is provided for aligning the central plunger stopper axis with the central image axis. The geometric dimensions of the plunger stopper are measured based on images of the plunger stopper.

[0018] Figures 1A and 1B show exemplary systems 100a and 100b for measuring the geometric dimensions of syringes and plunger stoppers. Systems 100a and 100b include a measurement system 105 having at least one imaging device 106, at least one optical probe 108 (e.g., an optical-based proximity sensor, light emitter, light receiver, etc.), and at least one illumination source 109 (e.g., a backlight, direct light, angled light, dark-field light, coaxial light, etc.), and at least one user interface 116. The user interface 116 may include a plurality of user interface displays 121 related to the measurement of the geometric dimensions of syringes 125a to 125d and / or plunger stoppers 160. The imaging device 106 includes a central image axis 107.

[0019] System 100 also includes a support platform 124 and a plunger stopper fixture mount 101. System 100 also includes a plunger stopper fixture 180 having an imaging device mount 182. When the imaging device mount 182 of the plunger stopper fixture 180 is attached to the plunger stopper fixture mount 101, the central plunger stopper axis 181 of the plunger stopper 160 is aligned with, and possibly intersects with, the central image axis 107. For example, the central plunger stopper axis 181 of the plunger stopper 160 may be aligned perpendicular to the central image axis 107. Further details regarding the measurement of the geometric dimensions of the plunger stopper 160 (e.g., overall length, width, angular alignment, etc.) will be described with reference to Figures 27 to 35.

[0020] Continuing to refer to Figure 1A, the system 100 also includes syringe fixtures 145a,d and an optical probe 108a. When the syringe fixtures 145a,d are placed on the support platform 124, the central syringe axes 126a,d of the syringes 125a,d are aligned with the central image axis 107 in a predetermined orientation. For example, the central syringe axes 126a,d may be aligned parallel to the central image axis 107. In some embodiments, the central syringe axes 126a,d may be aligned coaxially with the central image axis 107. Further details regarding the measurement of the geometric dimensions (e.g., barrel diameter) of the syringes 125a,d are described with reference to Figures 3 to 9 and Figure 26A.

[0021] A syringe jig 145c is also shown in Figure 1A, and the syringe jig 145c may be the same as syringe jigs 145a and d, in which the second plane 447c of the syringe jig 145c is close to the support platform 124. When the syringe jig 145c is placed on the support platform 124, the central syringe axis 126c of the syringe 125c is aligned with the central image axis 107 in a predetermined orientation. For example, the central syringe axis 126c may be aligned with the central image axis 107, and may intersect and be perpendicular to the central image axis 107. Further details relating to the measurement of the geometric dimensions of syringe 125b are described with reference to Figures 10–12 and 26B (e.g., Luer outer diameter), Figures 13, 14, and 26C (e.g., dosing line position), Figures 19–21 and 26E (e.g., barrel length), Figures 22, 23, and 26F (e.g., flange thickness), and Figures 24, 25, and 26G (e.g., barrel outer diameter).

[0022] Finally, as shown in Figure 1A, the system 100 may also include an alternative form of syringe fixture 145b (e.g., a Luer cap). When the syringe fixture 145b is coupled to the syringe 125b and placed on the support platform 124, the central syringe axis 126b of the syringe 125b is aligned with the central image axis 107 in a predetermined orientation. For example, the central syringe axis 126b may be aligned parallel to the central image axis 107. In some embodiments, the central syringe axis 126b may be aligned coaxially with the central image axis 107. Further details regarding the measurement of the geometric dimensions (e.g., flange diameter) of the syringe 125b using the syringe fixture 145b are described with reference to Figures 15-18 and 26D.

[0023] As shown in Figure 1B, the disclosed systems 100a,b include a measurement library 110 containing geometric dimensional data (e.g., barrel inner diameter, luer outer diameter, dosing line position, flange diameter, barrel length, flange thickness, barrel outer diameter, overall plunger stopper length, plunger stopper width, plunger stopper angle alignment, etc.). The geometric dimensional data may include digital image data representing images in which the relevant geometric dimensions are measured.

[0024] In some embodiments, systems 100a, b include two or more computers located at the same location as each other or at different locations from each other. In these distributed embodiments, the operations described herein relating to the processing unit 117 and the memory unit 118 may be divided among multiple processing units and / or memory units, respectively. System 100 may include algorithms for calculating various geometric dimensions (e.g., edge detection algorithms, pixel positioning algorithms, line orientation algorithms, etc.).

[0025] For example, the measurement system control module 120 and the measurement analysis module 119 may be stored in the memory unit 118 as a set of computer-readable instructions and executed by the processing unit 117 to measure the geometric dimensions of the syringe and / or plunger stopper.

[0026] The processing unit 117 comprises one or more processors, each of which may be a programmable microprocessor that executes software instructions stored in the memory unit 118 to perform some or all of the functions of the measurement system 105 as described herein. The processing unit 117 may include, for example, one or more artificial intelligence (AI) processing units and / or one or more central processing units (CPUs). Alternatively, or in addition, some of the processors in the processing unit 117 may be other types of processors (e.g., application-specific integrated circuits (ASICs), field-programmable gate arrays (FPGAs), etc.), and some of the functions of systems 100a,b as described herein may instead be implemented in hardware.

[0027] The memory unit 118 may include one or more volatile and / or non-volatile memories. The memory unit 118 may include one or more suitable types of memory, such as read-only memory (ROM), random access memory (RAM), flash memory, solid-state drives (SSDs), hard disk drives (HDDs), etc. Collectively, the memory unit 118 may store one or more software applications, data received / used by those applications, and data output / generated by those applications. In other embodiments, the memory unit 118 may omit one or more of modules 119, 120, and / or include one or more additional modules. In addition, or alternatively, one, some, or all of modules 119, 120 may be implemented by different computer systems (e.g., remote servers connected to system 115 via one or more wired and / or wireless communication networks). Furthermore, the functionality of either one of modules 119 and 120 may be divided between different software applications and / or computer systems. As just one example, in an embodiment in which systems 100a,b access a web service to train and use one or more geometric dimension measurement models, the software instructions for the measurement analysis module 119 may be stored on a remote server. The method for measuring geometric dimensions may be carried out by a processor (e.g., processing unit 117 in Figure 1B), which, for example, executes at least a portion of the measurement analysis module 119 and / or the measurement system control module 120.

[0028] Syringe jig As shown in Figures 3 to 9, for example, one variation of the syringe fixture 345a, d, 445a, d, 545a, d, 645a, d, 745a, d, 845a, d, 945a, d includes support blocks 543, 643 (see Figures 5 and 6) and syringe fixing mechanisms 599, 699 detachably coupled to the support blocks 543, 643 for securing syringes within the fixture. In some variations, the support blocks 543, 643 may include a first color (e.g., black) and the syringe fixing mechanisms 599, 699 may be a second color (i.e., white) different from the first color, so that the imaging system 100 can distinguish and identify the edge characteristics of, for example, two components.

[0029] In the disclosed embodiments, the support blocks 543, 643 comprise a support platform 524, 624 and a plurality of legs 453, 553 extending from the platforms 524, 624. In this modification, the support blocks 543, 643 include four legs 453, 553 whose proximal ends are attached to the support platform 524, 624 and whose distal ends are positioned away from the support platform 524, 624. Other modifications may include any number of legs suitable for achieving the intended purpose. As will be further described below, the disclosed configuration of the support blocks 543, 643 advantageously provides a fixture that can be used in different orientations to present a syringe in different orientations for capturing images and collecting measurements. To facilitate this purpose, and as shown in Figure 3, the distal ends of the legs 453, 553 include a flat distal end surface that collectively defines and / or lies within the first planar support surface 324. In addition, as shown in Figure 4, at least one of the multiple legs 453, 553 defines a side surface positioned perpendicular to the distal end surface of the leg 453, 553, the side surface at least partially defines and / or occupies a second planar support surface 424 perpendicular to the first planar support surface 324. As shown, the first planar support surface 324 includes a first edge 324a, and the second planar support surface 424 includes a second edge 424a connecting to the first edge 324a. Using the support blocks 543, 643 configured in this way, the syringe is oriented vertically when the first planar support surface 324 is positioned on the stage 124 of the system 100, and the syringe is oriented horizontally when the second planar support surface 424 is positioned on the stage 124 of the system 100, as can be seen in Figures 3 and 4. In other embodiments, other orientations are possible within the scope of this disclosure.

[0030] Referring again to Figures 5 and 6, the support platforms 524, 624 are shown to be substantially rectangular in shape (although other shapes are also possible) and define V-shaped notches 544, 644 in their side walls. The V-shaped notches 544, 644 are configured to work in cooperation with syringe fixing mechanisms 599, 699 to fix syringes 325, 425, 525, 625, 725, 825, 925 within the support blocks 543, 643. In some modifications, the V-shaped notches 544, 644 are configured to work in cooperation with syringe fixing mechanisms 599, 699 to center syringes 325, 425, 525, 625, 725, 825, 925 within the support blocks 543, 643.

[0031] Continuing to refer to Figures 5 and 6, the disclosed version of the syringe fixing mechanism 599, 699 includes syringe clamps 549, 649, V-shaped clamps 550, 650, wing nuts 552, 652, and springs 597, 697. The syringe clamps 549, 649 of the disclosed embodiment are substantially C-shaped and are slidably connected within a pair of slots on the sides of the support platforms 524, 624. The wing nuts 552, 652 pass through the openings of the syringe clamps 549, 649 and include a knurled knob and a shaft that carries a V-shaped clamp at the opposite end of the knurled knob. The springs 597 and 697 include compression supported on the shafts of the wing nuts 552 and 652, positioned between the syringe clamps 549 and 649 and the V-shaped clamps 550 and 650, such that the springs 597 and 697 push the V-shaped clamps 550 and 650 away from the syringe clamps 549 and 649 towards the V-shaped notches 544 and 644 on the support blocks 543 and 643. In this configuration, the springs 597 and 697 bias the V-shaped clamps 550 and 650, engaging with the syringes 525 and 625 located within the V-shaped notches 544 and 644, thereby fixing the syringes 525 and 625 in place.

[0032] Syringe measurement A method 2600a for measuring the geometric dimensions (e.g., barrel inner diameter 631) of syringes 325, 425, 525, 625, 725, 825, and 925 is described with reference to Figures 3 to 9 and Figure 26A. Systems 300, 400, 500, 600, 700, 800, and 900 may include syringe fixtures 345a, d, 445a, d, 545a, d, 645a, d, 745a, d, 845a, d, 945a, d and optical probes 808a, b. When the syringe jig is placed on the first planar support surface 324, the central syringe axes 326a, d, 426a, d, 526a, d, 626a, d, 726a, d, 826a, d, and 926a, d of the syringes 325, 425, 525, 625, 725, 825, and 925 are aligned with the central image axis 107 in a predetermined orientation. For example, the central syringe axes 326, 426, 526, 626, 726, 826, and 926 can be aligned parallel or coaxial with the central image axis 107.

[0033] The processing unit 117 may execute the measurement system control module 120 to cause the processing unit 117 to run a geometric dimension measurement program (block 2601a). The geometric dimension measurement program can be accessed from a drop-down list, for example, as shown in Figure 2. Lot number 222 in the field labeled "Lot" in the upper right corner of the program screen (block 2602a). The Luer cap 145b may be removed from the syringe 125b (block 2603a).

[0034] To position the syringes 525, 625 within the fixtures 500, 600, for example, the user can pull the wing nuts 552, 652 connected to the syringe clamps 549, 649, thereby compressing the springs 597, 697 and moving the V-shaped clamps 550, 650 away from the V-shaped notches 544, 644. The wing nuts 552, 652 may be connected to the V-shaped clamps 550, 650 and designed to be used as grips for pulling the V-shaped clamps 550, 650 (block 2604a). Syringe 425 may be rotated around the central syringe axis 426 within the fixture 445c so that the administration line cutout 430 faces downward (block 2605a). The user may pull the wing nuts 552, 652 to lower the syringe barrel until it contacts a flat surface (e.g., support platform 324), and rotate the syringe 325 as shown in Figure 5 to ensure that the width of the flange 1529 is horizontal to any edge. The parallelism of the flange to the edge can be approximated (block 2606a).

[0035] Next, the jig 645a is positioned on the stage 124 such that, for example, the jig 645a stands on the distal end surface of the leg portion 553 and the wing nut 652 faces as shown in Figure 6 (block 2607a). The flange portion of the syringe may be positioned together with the detection box 721 of the user interface display 700, for example, as shown in Figure 7 (block 2608a). The "Measure" button may be pressed as shown in Figure 7 (block 2609a).

[0036] The processing unit 117 executes the measuring device control module 120, for example, to swing the optical probe 808a arm from the side toward the stage 124, and advances it toward the side of the barrel 808b to perform barrel ID measurement, as shown in Figure 8 (block 2610a). Once the probe has performed all barrel ID measurements, the maximum barrel ID value may be displayed on the right side of the screen, as shown in Figure 9 (block 2611a). "Next" may be selected, as shown in Figure 9 (block 2612a), and the geometric dimension measurement program proceeds to the next measurement.

[0037] A method 2600b for measuring the geometric dimensions (e.g., Luer outer diameter 1032) of syringe 125b is described with reference to Figures 10-12 and 26B. Geometric dimension measuring systems 1000, 1100, and 1200 include syringe fixtures 1045c, 1145c, and 1245c. Syringe fixtures 1045c, 1145c, and 1245c may be similar to, for example, syringe fixture 145b. As will be described in detail with reference to Figures 3, 4, and 10-14, syringe fixtures 1045c, 1145c, and 1245c may be the same as syringe fixture 145b, with the second plane 447c of syringe fixture 145c being close to the support platform 124. When the syringe fixtures 1045c, 1145c, and 1245c are placed on the second planar support surface 424, the central syringe axes 1026, 1126, and 1226 of the syringes 1025, 1125, and 1225 are aligned with the central image axis 107 in a predetermined orientation. For example, the central syringe axes 1026, 1126, and 1226 can be aligned perpendicular to the central image axis 107.

[0038] The fixtures 1045c, 1145c, and 1245c may be rotated on the stage 124 without contacting the syringe barrel 1927, with the wing nuts facing upward and the Luer cones facing downward, as shown, for example, in Figure 10 (block 2613b). As shown in Figure 11, the Luer portion 1128 of the barrel is inside the detection box (block 2614b). As shown in Figure 11, the user may press the "Measure" button (block 2615b). The geometric dimension measurement program may be executed, and the measurement will be displayed on the right side of the screen as shown in Figure 12 (block 2615b). As shown in Figure 12, the "Next" icon may be pressed (block 2617b), and the program will proceed to the next measurement.

[0039] A method 2600c for measuring the geometric dimensions (e.g., administration line position 1333) of syringes 1325, 1425 is described with reference to Figures 13, 14, and 26C. The system 1300, 1400 includes syringe fixtures 1345c, 1445c. Syringe fixtures 1345c, 1445c may be similar to, for example, syringe fixture 145b. As will be described in detail with reference to Figures 3, 4, and 10-14, syringe fixtures 1345c, 1445c may be the same as syringe fixture 145b, with the second plane 447c of syringe fixture 145c being close to the support platform 124. When syringe fixtures 1345c and 1445c are placed on the support platform 124, the central syringe axes 1326 and 1426 of syringes 1325 and 1425 are aligned with the central image axis 107 in a predetermined orientation. For example, the central syringe axes 1326 and 1426 may be aligned perpendicular to the central image axis 107 (block 2618c). It is not necessary to change or adjust the fixture placement for this measurement. The user may orient the dosing line and Luer connector of the barrel as shown in Figure 13 (block 2619c). The "Measure" button may be selected as shown in Figure 13 (block 2620c). The geometric dimension measurement program is executed and all critical measurements may be displayed as shown in Figure 14 (block 2621c).

[0040] Fixtures 1345c and 1445c may be removed from stage 124 (block 2622c). The syringe may be removed from the fixture (block 2623c). The Luer cap may be placed back on the barrel (block 2624c). The user can view the results of each program by selecting the program from the drop-down menu under “Show Results” shown in Figure 14. The “Next” icon can be selected on the screen as shown in Figure 14 (block 2625c). Blocks 2620c to 2625c may be repeated for any additional Luer syringes that need to be tested for limit dimensions (block 2626c). Measurement data (e.g., geometric dimension measurements) may be stored (block 2627c). The user can return to the main menu screen by clicking the “Return to Main Menu” button (block 2628c). The user may exit the measurement system control module (block 2629c). The user may log out of the geometric measurement system (block 2630c).

[0041] A method 2600d for measuring the geometric dimensions (e.g., flange diameter 1534) of syringe 125b is described with reference to Figures 15-18 and 26D. Systems 1500, 1600, 1700, and 1800 include syringe fixtures 1545b, 1645b, 1745b, and 1845b (e.g., Luer caps). When syringe fixtures 1545b, 1645b, 1745b, and 1845b are placed on the support platform 124, the central syringe axes 1526, 1626, 1726, and 1826 of syringes 1525, 1625, 1725, and 1825 are aligned with the central image axis 107 in a predetermined orientation. For example, the central syringe axes 1526, 1626, 1726, and 1826 can be aligned parallel to the central image axis 107.

[0042] The processing unit 117 may further execute the measurement system control module 120 to load a geometric dimension measurement program into the processing unit 117, for example, as shown in Figure 2 (block 2631d). The user may enter lot number 222 in a field labeled "Lot" (block 2632d). Syringe fixtures 1545b, 1645b, 1745b, and 1845b are positioned vertically on the stage 124 with the flange side facing upward, as shown in Figure 15 (block 2633d). The syringe barrels are oriented on the stage 124 such that the flange cutout is either horizontal or perpendicular to the stage (block 2634d). The "Measure" button may be selected, as shown in Figure 17 (block 2635d). The processing unit 117 executes the measurement analysis module 119 to cause the processing unit 117 to generate a measurement display on the right side of screen 1821, for example, as shown in Figure 18 (block 2636d). The user can select "Next" as shown in Figure 18 (block 2637d), and the geometric dimension measurement program proceeds to the next measurement (block 2638d).

[0043] A method 2600e for measuring the geometric dimensions (e.g., barrel length 1935) of syringes 1925, 2025, and 2125 is described with reference to Figures 19 to 21 and Figure 26E. Systems 1900, 2000, and 2100 include syringe fixtures 1945c, 2045c, and 2145c. Syringe fixtures 1945c, 2045c, and 2145c may be similar to, for example, syringe fixture 145b. As will be described in detail with reference to Figures 3, 4, and Figures 10 to 14, syringe fixtures 1945c, 2045c, and 2145c may be the same as syringe fixture 145b, with the second plane 447c of syringe fixture 145c being close to the support platform 124. When the syringe fixtures 1945c, 2045c, and 2145c are placed on the support platform 124, the central syringe axes 1926, 2026, and 2126 of the syringes 1925, 2025, and 2026 are aligned with the central image axis 107 in a predetermined orientation. For example, the central syringe axes 1926, 2026, and 2126 may be aligned perpendicular to the central image axis 107.

[0044] The Luer cap can be removed (e.g., by loosening the screw) (block 2639e). Syringes 1925, 2025, and 2125 may be placed in syringe fixtures 1945c, 2045c, and 2145c as shown in Figure 3 (block 2640e). The wing nut may be connected to the clamp and may be designed to be used as a grip for pulling the syringe barrel clamp, but not designed to be screwed (block 2641e). The wing nut may be pulled, lowering the syringe barrel until the syringe barrel hits a flat surface, and the barrel may be rotated to ensure that the flange width is horizontal to any edge of syringe fixtures 1945c, 2045c, and 2145c as shown in Figure 4 (block 2642e). The parallelism of the flange to the edge can be approximated (block 2643e). Fixtures 1945c, 2045c, and 2145c are positioned on the stage without contacting the syringe barrel, with the wing nuts facing upward and the Luer cones facing downward, as shown in Figure 19. The user may align the fixtures as shown in Figure 20.

[0045] As shown in Figure 20, the "Measure" button may be selected (block 2644e). The geometric dimension measurement program is executed, and the program performs two measurements, with the average displayed on the right side of the screen as shown in Figure 21 (block 2645e). The user can select the "Next" icon as shown in Figure 21 (block 2646e), and the program proceeds to the next measurement.

[0046] A method for measuring the geometric dimensions (e.g., flange thickness 2236) of syringes 2225, 2325 is described with reference to Figures 22, 23 and 26F. The systems 2200, 2300 include syringe fixture 145c. Syringe fixtures 2245c, 2345c may be similar to, for example, syringe fixture 145b. As will be described in detail with reference to Figures 3, 4 and 10-14, syringe fixtures 2245c, 2345c may be the same as syringe fixture 145b, with the second plane 447c of syringe fixture 145c being close to the support platform 124. When syringe fixtures 2245c, 2345c are placed on the support platform 124, the central syringe axes 2226, 2326 of syringes 2225, 2325 are aligned with the central image axis 107 in a predetermined orientation. For example, the central syringe axes 2226 and 2326 can be aligned perpendicular to the central image axis 107.

[0047] The jig is placed on the stage 124, and the flange portion 2228 is placed inside the detection box as shown in Figure 22 (block 2647f). The "Measure" button may be selected as shown in Figure 22 (block 2648f). The processing unit 117 may execute the measurement system control module 120 to start the geometric dimension measurement program on the processing unit. The program performs two measurements and displays the maximum value on the right side of the screen as shown in Figure 23 (block 2649f). The "Next" icon may be selected as shown in Figure 23 (block 2650f), and the program proceeds to the next measurement.

[0048] A method for measuring the geometric dimensions (e.g., barrel outer diameter 2437) of syringes 2425, 2525 is described with reference to Figures 24, 25 and 26G. The system 2400, 2500 includes syringe fixtures 2445c, 2545c. Syringe fixtures 2445c, 2545c may be similar to, for example, syringe fixture 145b. As will be described in detail with reference to Figures 3, 4 and 10-14, syringe fixtures 2445c, 2545c may be the same as syringe fixture 145b, with the second plane 447c of syringe fixture 145c being close to the support platform 124. When the syringe fixtures 2445c and 2545c are placed on the support platform 124, the central syringe axes 2426 and 2526 of the syringes 2425 and 2525 are aligned with the central image axis 107 in a predetermined orientation. For example, the central syringe axes 2426 and 2526 can be aligned perpendicular to the central image axis 107.

[0049] No changes or adjustments to the fixture's position are necessary for this measurement (block 2651g). The fixture must be placed within the detection box on the screen, as shown in Figure 24 (block 2652g). The "Measure" button may be selected as shown in Figure 24 (block 2653g). The processing unit 117 can run the measurement system control module 120 to cause the processing unit 117 to generate a display 2421 of all major B measurements for the four programs, for example, as shown in Figure 25 (block 2654g). The fixture may be removed from the stage 124 (block 2655g). The syringe may be removed from the fixture (block 2656g). The Luer cap can be screwed back onto the barrel (block 2657g). The user can view the results for each program by selecting the program from the drop-down menu under "Show Results" shown in Figure 25. The "Next" icon may be selected on the screen, as shown in Figure 25 (2658g). Blocks 2653g to 2658g can be repeated for additional Luer syringes that need to be tested for the main B dimension (block 2659g). Geometric dimension measurement data may or may not be stored (block 2660g). The user can return to the main menu screen by clicking the "Return to Main Menu" button in the upper right corner (block 2661g). The user can log out of the system (block 2662g). The user can turn off the system by pressing the "Power" button if necessary (block 2663g).

[0050] Three critical dimensions and four major B dimensions can be measured. The raw data output may include all measured values, mean, and standard deviation for each dimension for critical distance (K) calculation.

[0051] Plunger stopper jig As referred to herein, this application also discloses a method and system for measuring a plunger stopper using an imaging system 200. To assist in this process, a plunger stopper fixture 180 is provided. The plunger stopper fixture 180 is described in more detail in Figures 28 and 29 and includes a base 2987 and a plunger stopper rotation mechanism 2999 (shown in Figure 28) coupled to the base 2987 for holding and rotating the plunger stopper to be measured. The base 2987 includes a substantially flat support structure that can be screwed to or otherwise fixed to a stage 124 of the imaging system 100, as shown in Figure 28. Continuing to refer to Figure 28, the plunger stopper rotation mechanism 2999 includes a dial 2884 and a rod 2888. The dial has a dial axis 2889 around which the dial rotates. Rod 2888 has a proximal end coupled to dial 2884 and extends along dial axis 2889, rotating as dial 2884 rotates, and also rotating around dial axis 2889. Rod 2888 further includes a distal end located away from dial 2884. The distal end of rod 2888 defines a plunger stopper retaining tip 2883 for coupling a plunger stopper to a fixture. In some modifications, the plunger stopper retaining tip 2883 may include, for example, a male thread for screwing into the cavity of the plunger stopper. Other configurations for attaching the plunger stopper to the distal end of rod 2888 are also possible. As seen in Figure 29, dial 2884 includes a rotation angle gauge (e.g., rotation angle index) on its outside. In some modifications, dial 2884 may include nine rotation indices, each representing a 20-degree rotation, as described below, thereby capturing nine images and representing a total rotation of 180 degrees to determine the relevant dimensions. Other embodiments may include any number of indices and rotational positions.

[0052] Plunge stopper measurement A method 3500 for measuring the geometric dimensions of the plunger stopper 160 (e.g., total length 3063, width 3062, angular alignment 3464, etc.) is described with reference to Figures 27 to 35. Systems 2700, 2800, 2900, 3000, 3100, 3200, 3300, 3400, and 3500 include a plunger stopper fixture 180 having a base 2987 (shown in Figure 29) for fixing to the stage 124 of the imaging system, for example, as shown in Figures 1 and 28. When the imaging device mounts 182, 2982 of the plunger stopper fixture 180 are attached to the plunger stopper fixture mount 101, the central plunger stopper axes 181, 2861 of the plunger stopper 160 align with the central image axis 107 and, if applicable, intersect with the central image axis 107. For example, referring to Figure 35, the central plunger stopper axes 181 and 2861 of the plunger stopper 160 are aligned perpendicular to the central image axis 107, and may intersect with the central image axis 107 in order to initiate the measurement procedure (block 3501).

[0053] The plunger stopper fixture 180 may be mounted on the stage 124, for example, using appropriate screw holes and two M4 socket head screws (block 3502). For example, the two M4 socket head screws may be hand-tightened so that the fixture 180 is rigid on the stage, as shown in Figure 10. M4 screws and any screws of 10 to 13 mm in length can be used to mount the plunger stopper fixture 180. The Keyence program has three possible results: i. The measurement result is displayed as "OK" on the right side of the Keyence screen. This means that the measured value for this limit dimension is within the specification limits. In this case, refer to the Test Methods section for appropriate data recording requirements. ii. The measurement result is displayed as "NG" on the right side of the screen. This means that the measured value for this limit dimension is outside the specification limits. In this case, refer to the Test Methods section for appropriate data recording requirements. iii. The result is displayed as "Fail" on the right side. This means that the pattern was not detected correctly or pattern recognition failed. This does not necessarily mean that the sample is out of specification. The user may enter plunger stopper lot number 222 in the lot number field located in the upper right corner of screen 200 (block 3503). The cavity on the rear side of the plunger stopper may be positioned on the plunger stopper retaining tip 2883 at the distal end of rod 2888 (block 3504). This may include screwing the plunger stopper onto the tip, inserting the plunger stopper onto the tip by friction fit, or other means. The user may ensure that the plunger stopper 2860 is fully seated on the retaining tip 2883 by lightly tapping the tip of the plunger stopper.

[0054] The user may ensure that the plunger stopper is parallel to the stage by ensuring that the general position of the plunger stopper does not change when the fixture is rotated, as shown in Figure 28 for visualization purposes. Using the markers 2889, 2989, 3189a, and 3189b on dials 2884, 2984, 3184a, and 3184b as a reference, set the fixture's rotation dial to one of the 90° marks as shown in Figures 28, 29, and 31 (block 3505). The user can select the "Measure" button (block 3506). Once the measurement is complete (blocks 3507-3509), the dimensions of the plunger stopper are displayed (block 3510). Figure 30 shows an exemplary display 3100. The user can select the "Next" button on the screen to move to the next measurement (block 3507). Using the markers on the dial as a reference, the user can rotate the dial on the fixture by 20° as shown in Figure 31. Blocks 3506-3508 are repeated for a total of nine 20° increment angles (block 3509). All rotations are in the same direction. Once measurements from nine angles are complete, the program finishes and displays an overview of all nine measurements and three results for each dimension: average, maximum, and minimum, all of which are calculated from the nine measurements. The program may have one or more dimensions depending on the plunger stopper and its defect classification. Figure 32 shows an exemplary display 3200 of the plunger. The average of the nine measurements for each dimension is displayed as the name of that dimension, without any preceding or following words, for example, "Coated Outer Diameter" or "Overall Length". The user can click on the image of each measurement to display the image of that measurement in full screen 3300, 3400 in Figures 33 and 34. Figure 33 shows dust / hair / debris 3395. The user can click on the image on screens 3300, 3400 to return to the overview. The measured plunger stopper may be removed and stored or discarded according to the appropriate procedure (block 3512). The user can restart the program by clicking the "Next" button (block 3519). Note that the serial counter will roll to the following integer.Blocks 3503-3513 may be repeated until all plunger stoppers have been tested (block 3514). If two or more recipes repeat blocks 3503-3513 for each recipe, the user can verify how many recipes exist for a sample type. If there is only one recipe for a sample type, proceed to the next step (block 3515) and return to the main menu screen by clicking the "Return to Main Menu" button in the upper right corner of Figure 34 (block 3516). The plunger stopper retaining tip 2883 may be removed from the rod 2888 by loosening the screws (block 3517). The plunger stopper fixture 180 may be removed by loosening the two M4x10 socket head screws (block 3518). The user may log out and / or shut down the system as needed (block 3519).

[0055] Systems, methods, apparatus, and their components have been described in terms of exemplary embodiments, but they are not limited to these exemplary embodiments. Detailed descriptions are to be interpreted as examples only, and since it would be impractical, if not impossible, to describe all possible embodiments, not all possible embodiments of the present invention are described. Many alternative embodiments can be carried out using either the current art or art developed after the filing date of this patent, and these still fall within the scope of the claims defining the present invention.

[0056] Those skilled in the art will understand that various modifications, variations, and combinations of the above embodiments can be made without departing from the scope of the present invention, and that such modifications, variations, and combinations are to be interpreted as being within the scope of the concept of the present invention.

Claims

1. A syringe jig configured to align the central syringe axis of the syringe with the central image axis of the imaging system, A support block defining a V-shaped notch, a first planar support surface, and a second planar support surface, The first planar support surface has a first edge, The support block comprises a second planar support surface having a second edge, at least a portion of which is connected to at least a portion of which is connected to the first edge, and the second planar support surface being perpendicular to the first planar support surface. A syringe jig comprising: a syringe fixing mechanism coupled to the support block and configured to fix the syringe to a fixed position within the V-shaped notch, wherein the syringe occupies a first orientation when the support block is positioned on the first planar support surface, and the syringe occupies a second orientation perpendicular to the first orientation when the support block is positioned on the second planar support surface.

2. The syringe jig according to claim 1, wherein the syringe fixing mechanism includes a V-shaped clamp facing the V-shaped notch and is configured to engage with the syringe to fix the syringe within the V-shaped notch.

3. The syringe jig according to claim 2, wherein the syringe fixing mechanism further comprises a syringe clamp that is detachably coupled to the support block and connected to the V-shaped clamp.

4. The syringe fixing mechanism further comprises a spring positioned between the syringe clamp and the V-shaped clamp, the spring biasing the V-shaped clamp away from the syringe clamp, according to claim 3.

5. The syringe jig according to any one of claims 1 to 4, wherein the support block comprises a support platform defining the V-shaped notch, and a plurality of legs having a proximal end attached to the support platform and a distal end positioned away from the support platform, the distal ends having distal end surfaces that collectively define the first planar support surface.

6. The syringe jig according to claim 5, wherein at least one of the plurality of legs defines a side surface positioned perpendicular to the distal end surface, and the side surface defines at least partially the second planar support surface.

7. The syringe fixture according to any one of claims 1 to 6, wherein the support block includes a first color, and the syringe fixing mechanism includes a second color different from the first color.

8. The syringe jig according to any one of claims 1 to 7, wherein the first orientation is vertical and the second orientation is horizontal.

9. A system for measuring at least one geometric dimension of a syringe, A syringe imaging system having a central imaging axis and a stage plane, A syringe jig configured to fix the syringe in a first orientation with respect to the central imaging axis when the support block is placed on a first planar support surface, An image sensor, fixed by the syringe jig and positioned on the first plane, is configured to capture a first image of at least a portion of the syringe. A system comprising one or more processors configured to generate at least one geometric measurement of the syringe based on at least the first image.

10. The system according to claim 9, wherein the syringe fixture includes the syringe fixture described in any one of claims 1 to 8.

11. The system according to claim 9, wherein the syringe fixture is equipped with a Luer cap.

12. The system according to any one of claims 9 to 11, further comprising an optical probe configured to be inserted into the barrel of the syringe.

13. The system according to any one of claims 9 to 12, further comprising a backlight positioned on the opposite side of the stage plane from the image sensor.

14. The system according to any one of claims 9 to 13, further comprising a display device configured to display the at least one geometric dimension of the syringe.

15. A method for measuring the geometric dimensions of a syringe, The syringe is fixed inside the syringe jig, The syringe and syringe jig are positioned at a first position on the stage plane of the imaging system, wherein the syringe has a central syringe axis that occupies a first predetermined orientation with respect to the central image axis of the imaging system. Using the image sensor of the imaging system, acquire at least one image of at least a portion of the syringe, A method comprising calculating at least a first geometric dimension of the syringe based on the at least one image using the processor of the imaging system.

16. The method according to claim 15, wherein fixing the syringe in a syringe jig includes fixing a Luer cap to the distal end of the syringe, and arranging the syringe and the syringe jig on the stage plane includes arranging the syringe vertically on the stage plane so as to be supported by the Luer cap.

17. The method according to claim 15, wherein fixing the syringe within the syringe jig includes fixing the syringe within a V-shaped notch of the support block of the syringe jig.

18. The method according to claim 17, further comprising engaging the syringe with a V-shaped clamp facing the V-shaped notch to fix the syringe within the V-shaped notch.

19. The method according to claim 18, further comprising removably coupling a syringe clamp to the support block, wherein the syringe clamp is connected to the V-shaped clamp.

20. The method according to claim 19, further comprising biasing the V-shaped clamp away from the syringe clamp while the spring is positioned between the syringe clamp and the V-shaped clamp.

21. The method according to any one of claims 17 to 20, wherein the support block further comprises a first planar support surface, the first plane contacting the stage plane when the syringe and syringe jig occupy the first position and the first predetermined orientation.

22. The method according to claim 21, wherein the support block further comprises a second planar support surface perpendicular to the first planar support surface, and the second plane contacts the stage plane when the syringe and syringe jig occupy a second position having a second predetermined orientation perpendicular to the first predetermined orientation.

23. The method according to claim 22, wherein the support block comprises a support platform defining the V-shaped notch, and a plurality of legs having a proximal end attached to the support platform and a distal end positioned away from the support platform, the distal ends having a distal end surface collectively defining the first plane, and at least one of the plurality of legs defining a side surface positioned perpendicular to the distal end surface, the side surface at least partially defining the second plane.

24. The method according to claim 22 or 23, wherein the first predetermined orientation is vertical and the second predetermined orientation is horizontal.

25. The method according to any one of claims 17 to 24, wherein calculating the at least first geometric dimensions includes calculating (a) the inner diameter of the syringe barrel, (b) the diameter of the syringe flange, (c) the outer diameter of the Luer connector, (d) the position of the syringe dispensing line, (e) the length of the syringe barrel, (f) the thickness of the syringe flange, and / or (g) the outer diameter of the syringe barrel.

26. A plunger stopper fixture configured to align the central plunger stopper axis with the central image axis of the imaging system, A base comprising an imaging system mounting fixture configured to be fixed in a fixed position relative to the stage of an imaging system having a central image axis, A plunger stopper rotation mechanism coupled to the base, the plunger stopper rotation mechanism comprising a dial rotatable about a dial axis and a rod extending from the dial along the dial axis, the rod having a distal end positioned away from the dial, the distal end of the rod having a plunger stopper holding tip configured to fix the plunger stopper to the plunger stopper fixture and to align with the central image axis, The plunger stopper rotation mechanism is configured such that the central plunger stopper axis of the plunger stopper is aligned coaxially with the dial axis, and when the dial rotates around the dial axis, the plunger stopper rotates around the central plunger stopper axis.

27. The plunger stopper jig according to claim 26, wherein the plunger stopper holding tip is provided with a threaded male end configured to be screwed into the cavity of the plunger stopper.

28. The plunger stopper fixture according to claim 26 or 27, wherein the dial is equipped with a rotation angle gauge.

29. The plunger stopper fixture according to claim 28, wherein the rotation angle gauge includes at least nine rotation indices.

30. The plunger stopper fixture according to claim 29, wherein each of the at least nine rotational indices indicates a rotation of 20 degrees relative to the adjacent index.

31. A system for measuring at least one geometric dimension of a plunger stopper, A plunger stopper imaging device having a central imaging axis, A plunger stopper jig having a plunger stopper rotation mechanism, wherein the plunger stopper jig is configured to fix the plunger stopper to the plunger stopper imaging device with the central plunger stopper axis aligned with the central image axis, the plunger stopper rotation mechanism is configured to rotate the plunger stopper around the central plunger stopper axis, the plunger stopper imaging device captures a first image of at least a portion of the plunger stopper with the plunger stopper oriented at a first rotation angle around the central plunger stopper axis, and the plunger stopper imaging device captures a second image of at least a portion of the plunger stopper with the plunger stopper oriented at a second rotation angle around the central plunger stopper axis. A system comprising: a geometric measurement generation device configured to generate at least one geometric measurement of the plunger stopper based on the first image and the second image.

32. The system according to claim 31, wherein the plunger stopper rotation mechanism includes a plunger stopper holding tip configured to detachably fix the plunger stopper to the plunger stopper jig.

33. The system according to claim 31 or 32, wherein the plunger stopper imaging device includes a plunger stopper jig mounting fixture, and the plunger stopper jig includes a plunger stopper imaging device mounting fixture configured to detachably attach the plunger stopper jig to the plunger stopper imaging device.

34. The system according to any one of claims 31 to 33, further comprising a backlight positioned on the opposite side of the stage plane from the image sensor.

35. The system according to any one of claims 31 to 34, further comprising a display device configured to display the at least one geometric dimension of the plunger stopper.

36. A method for measuring at least one geometric dimension of a plunger stopper, The central plunger stopper axis of the plunger stopper is positioned at a fixed angle with respect to the central image axis of the imaging device, and at the initial rotation angle around the central plunger stopper axis. Using an imager, capture a first image of the profile diagram of the plunger stopper while the plunger stopper is oriented at the initial rotation angle around the central plunger stopper axis. Using a processor, determine a first value for at least one geometric dimension of the plunger stopper based on the first image, Rotating the plunge stopper around the central plunge stopper axis to a second rotation angle, Using the imager, capture a second image of the profile diagram of the plunger stopper while the plunger stopper is oriented to the second rotation angle. A method comprising using the processor to determine a second value for the at least one geometric dimension of the plunger stopper based on the second image.

37. The method according to claim 36, further comprising using the processor to determine the minimum, maximum, and average values ​​of the at least one geometric dimension.

38. The method according to claim 36 or 37, wherein the at least one geometric dimension includes (a) the outer diameter of the plunger stopper, (b) the outer diameter of the coated plunger stopper, and / or (c) the overall length of the plunger stopper.

39. The method according to any one of claims 36 to 38, wherein the at least one geometric dimension depends on the type of plunger stopper.

40. The method according to any one of claims 36 to 39, wherein the at least one geometric dimension depends on the classification of a potential plunger stopper defect.

41. The method according to any one of claims 36 to 40, further comprising using the processor to determine whether the at least one geometric dimension is above a minimum threshold and below a maximum threshold.

Images