Method and system for automated syringe quality assessment - Patents.com

JP2024516113A5Pending Publication Date: 2025-04-02AMGEN INC
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Patent Information

Application Number
JP2023562211
Authority / Receiving Office
JP · JP
Patent Type
Applications
Current Assignee / Owner
Priority Date
2021-04-22
Filing Date
2022-04-12
Publication Date
2025-04-02

AI Technical Summary

Technical Problem

Current methods for measuring plunger depth in prefilled syringes are manual and prone to errors, leading to failed quality control due to incorrect plunger depth measurements.

Method used

An automated syringe measurement system using an imaging system with a camera, illumination source, and alignment device, coupled with a processor to determine plunger depth within syringes, allowing for simultaneous and accurate measurement of multiple syringes.

Benefits of technology

The automated system provides precise and efficient plunger depth measurements, reducing human error, increasing throughput, and ensuring consistent quality control without the need for extensive personnel.

✦ Generated by Eureka AI based on patent content.

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Abstract

An automated syringe quality control system, apparatus and method are provided that can determine plunger depth in a syringe pre-filled with a drug, the plunger depth may be based on digital image data.
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Description

[Technical field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS Priority is claimed to U.S. Patent Application No. 63 / 178,339, filed April 22, 2021, the entire contents of which are expressly incorporated herein by reference.

[0002] The present disclosure relates to syringe manufacturing and quality control, and more particularly, to methods and apparatus for automated syringe quality control imaging. [Background technology]

[0003] Many pharmaceutical products are manufactured and stored in syringes and manufactured to the highest quality standards. Some pharmaceutical products include pre-filled syringes with pre-measured doses stored in the syringe barrel. Properly manufactured pre-filled syringes have unique plunger depth requirements. Plunger depth is unique based on the drug, container, and fill volume. Therefore, for a given drug, container, and fill volume, the depth at which the plunger is placed in the syringe barrel is a controlled variable.

[0004] Since plunger depth is a controlled variable for all prefilled syringe cartridges, one aspect of the quality control process is to verify the plunger depth in the manufactured syringe.Currently, plunger depth is measured manually by laboratory technicians using calipers.If the plunger depth does not match the plunger depth corresponding to the specific drug product, the syringe will fail this quality control process. Summary of the Invention [Means for solving the problem]

[0005] The automated syringe measurement system may include an imaging system capable of generating imaging data. The imaging system may include a camera, an imaging surface, and an illumination source. The automated syringe measurement system may also include an alignment device for aligning the at least one syringe with respect to the imaging system. The automated syringe measurement system may further include a processor configured to receive the imaging data from the imaging system and determine whether a depth of a plunger within a barrel of the at least one syringe is within a predetermined tolerance.

[0006] In another embodiment, the syringe-carrying container assembly may include a container configured to accommodate a plurality of syringes. The syringe-carrying container assembly may also include a syringe carrier plate having a plurality of apertures extending from a top surface of the syringe carrier plate to a bottom surface of the syringe carrier plate. Each of the plurality of apertures may be configured to accommodate one of the plurality of syringes. The syringe-carrying container assembly may further include a container insert configured to be placed in the container before the plurality of syringes are placed in the container. The container insert may include at least one syringe elevator aligned with at least one of the plurality of syringes. When the syringe carrier plate, the container insert, and the plurality of syringes are placed in the container, the at least one syringe elevator may be configured to elevate the at least one syringe positioned to be accommodated in the at least one aperture aligned with the syringe elevator relative to the remaining syringes of the plurality of syringes.

[0007] In a further embodiment, the syringe extraction tool may include a syringe carrier having a first end, a second end, and a plurality of syringe receptacles arranged linearly along an edge of the syringe carrier from the first end to the second end. The syringe extraction tool may also include a stationary gripper having a first end and a second end. The first end of the syringe carrier may be connected to the first end of the stationary gripper via a first sliding rod. The second end of the syringe carrier may be connected to the second end of the stationary gripper via a second sliding rod. The syringe extraction tool may further include a syringe retainer portion having a first end, a second end, and a plurality of spring-biased syringe retainers arranged linearly along the syringe holder from the first end to the second end. Each spring biased syringe retainer may be configured to retain a corresponding syringe in a corresponding syringe receptacle independent of any other spring biased syringe retainer in the plurality of spring biased syringe retainers. A first end of the syringe retainer portion may be configured to slide along a first sliding rod. The first end of the syringe retainer portion may be biased toward a first end of the syringe carrier portion via a first syringe retainer portion biasing spring. A second end of the syringe retainer portion may be configured to slide along a second sliding rod. The second end of the syringe retainer portion may be biased toward a second end of the syringe carrier portion via a second syringe retainer portion biasing spring.

[0008] In yet another embodiment, the syringe rack may include a plurality of syringe receptacles. At least one syringe receptacle may include an open end defining a syringe barrel receptacle. The syringe barrel receptacle may be configured to receive a syringe barrel. Each syringe receptacle may be configured to align a corresponding syringe in a predetermined orientation with respect to the syringe rack.

[0009] The present disclosure will be more fully understood when the following description is taken in conjunction with the accompanying drawings, in which: Some of the drawings may be simplified by omitting selected elements to more clearly show other elements. Such omission of elements in some of the drawings does not necessarily indicate the presence or absence of the particular elements in any of the illustrative embodiments, unless expressly expressed in the corresponding description. Additionally, none of the drawings are necessarily drawn to scale. [Brief description of the drawings]

[0010] [Figure 1A] 1 illustrates an exemplary automated digital image sensor based syringe plunger depth determination system. [Figure 1B] 1 shows a high level block diagram of an exemplary automated digital image sensor based syringe plunger depth determination system. [Figure 1C] 1A-1D show various views of an exemplary automated digital image sensor based syringe plunger depth determination device. [Figure 1D] 1A-1D show various views of an exemplary automated digital image sensor based syringe plunger depth determination device. [Figure 1E] 1A-1D show various views of an exemplary automated digital image sensor based syringe plunger depth determination device. [Figure 1F] 1 illustrates an exemplary remote computing device for use within an automated digital image sensor based syringe plunger depth determination system. [Figure 2A] 1 illustrates a perspective view of an exemplary alignment rack. [Figure 2B] 1 illustrates a perspective view of an exemplary alignment rack. [Figure 2C] 1 illustrates a perspective view of a portion of an exemplary alignment rack for corresponding syringes. [Figure 3A] 1 illustrates a perspective view of an exemplary container being filled with a syringe. [Figure 3B] 1 illustrates a perspective view of an exemplary container insert. [Figure 4A]1 illustrates a perspective view of an exemplary syringe removal tool. [Figure 4B] 1 illustrates a perspective view of a portion of an exemplary syringe removal tool relative to a corresponding syringe. [Figure 4C] 1 illustrates a profile view of a deployed portion of an exemplary syringe removal tool in operative relationship to a corresponding portion of a syringe. [Figure 4D] 1 illustrates a perspective view of an exemplary syringe removal tool in operative relationship to a syringe container. [Figure 4E] 1 shows a perspective view of several exemplary syringes. [Figure 4F] 1 illustrates an exemplary side view of a number of exemplary syringes. [Figure 4G] 1 illustrates an exemplary side view of multiple syringes. [Diagram 5] 1 illustrates a perspective view of an exemplary imaging device syringe alignment adapter. [Figure 6A] 1 shows a perspective view of a plurality of exemplary syringes disposed on an imaging surface of an exemplary imaging device. [Figure 6B] 1 shows a perspective view of a plurality of exemplary syringes aligned on an imaging surface of an exemplary imaging device. [Figure 7A] 1 illustrates a side view of an exemplary syringe alignment relative to a camera. [Figure 7B] 13 shows an exemplary display of plunger depth measurements for multiple syringes. [Figure 7C] 13 shows an exemplary display of correct and incorrect plunger depth measurements. [Figure 7D] 1 illustrates an exemplary method of syringe plunger insertion and equilibration. [Figure 7E] 1 illustrates a side view of an exemplary plunger depth measurement. [Figure 8A] 1 shows a block diagram of an exemplary measurement device. [Figure 8B] 1 illustrates an exemplary method of operating a measurement device. [Figure 9A] FIG. 1 shows a block diagram of a remote computing device for use in a syringe inspection system. [Figure 9B] 1 illustrates an exemplary method of operating a remote computing device for use in a syringe inspection system. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0011] Those skilled in the art will appreciate that the elements in the figures are depicted for simplicity and clarity and are not necessarily drawn to scale. For example, the dimensions and / or relative positions of some of the elements in the figures may be exaggerated relative to other elements to help improve understanding of the various embodiments of the present invention. Also, common but well-understood elements that are useful or necessary in commercially feasible embodiments are often not shown in order to not overly distract from the views of these various embodiments. Furthermore, it will be appreciated that although certain acts and / or steps may be described or shown in a particular order of occurrence, those skilled in the art will appreciate that such specificity with respect to the order is not actually required. Furthermore, it will be appreciated that although certain acts and / or steps may be described or shown in a particular order of occurrence, those skilled in the art will appreciate that such specificity with respect to the order is not actually required. It will also be appreciated that the terms and expressions used herein have the ordinary technical meanings as given to such terms and expressions by those skilled in the art, as set forth above, unless a different specific meaning is explained herein.

[0012] Some quality control processes for prefilled syringes (e.g., prefilled 1 mL syringes, prefilled 0.5 mL (Terumo) syringes, products, prefilled 2.25 mL syringes, 5 mL cartridges, etc.) are currently handled manually by technicians. For example, one quality control process for prefilled syringes involves measuring the depth to which the plunger is inserted into the syringe barrel. The depth of the plunger in the syringe barrel is unique for a given drug product based on the drug, container, and fill volume. As a result, for a given drug product, if the plunger is at an incorrect depth, the syringe fails quality control. Currently, the depth of the plunger is typically measured manually using a caliper. As often used in the context of drug delivery, in this specification, the "distal" end of the syringe generally means away from the patient, and "proximal" means toward the patient.

[0013] According to the present disclosure, the syringe plungers can be imaged and the plunger depth can be measured using digital image data representing the image of the syringe. For example, multiple syringes can be imaged by a camera and a processor can measure the multiple syringes simultaneously. In such an embodiment, the syringes can be placed on an imaging surface of a measurement device to align the multiple syringes. The syringes can then be appropriately illuminated and an image of the illuminated syringes can be taken. The processor can then measure the depth of at least one plunger in a corresponding syringe based on the image data. As a result, instead of manually measuring the depth of each plunger, multiple syringes can be measured simultaneously and more accurately than before.

[0014] Automated syringe measurement systems are generally more precise and accurate than manual measurement methods. In addition, the use of an automated syringe measurement system ensures that quality data and batch numbers are automatically recorded. Furthermore, automated syringe measurement systems process more syringes per minute than manual measurement techniques. Furthermore, some automated systems according to the present disclosure require fewer operating personnel. As a result, the automated syringe measurement system of the present disclosure may be superior to current manual syringe quality control procedures.

[0015] 1A, a measurement device 105a (e.g., Keyence IM-7030 available from Keyence Corporation, 500 Park Boulevard, Suite 200, Itasca, Ill. 60143; PID TRPT-031206 vision system; DASI vision system, etc.) can be configured to determine a plunger depth in at least one syringe 152a, 120a, 127a. A plurality of syringes 152a (e.g., a plurality of pre-filled syringes, a plurality of pre-filled syringe cartridges, etc.) can be transported from a production process, for example, via a container 150a and a syringe carrier plate 151a. A syringe 152a can be removed from the container 150a and the syringe carrier plate 151a, for example, via a syringe removal tool 170a. The measurement device 105a may be calibrated (eg, trained, etc.) using the rack of syringes 140a. The measurement device 105a may be communicatively connected to a remote computing device 125a.

[0016] The measurement device 105a may also include a digital camera 106a (e.g., a camera including a CMOS or CCD imaging sensor, etc.), a target orientation sensor 107a, an imaging surface 108a having at least one alignment feature 117a, a display device 110a having multiple user interface displays 120a, a user control panel 111a, a manual imaging surface / camera orientation / focus control 112a, a mouse 113a, a keyboard 114a, and a printer 121a. The remote device 125a may include a display device 126a having multiple user interfaces 127a, a keyboard 128a, a mouse 129a, and a printer 134a. The syringe extraction tool 170a may include multiple syringe receptacles 173a, and spring-loaded syringe retaining portions 171a / 172a. The syringe rack 140a may include a number of syringes 141a, 142a secured in a predetermined orientation to the corresponding syringe rack 140a. Further details of the measurement device 105a, remote device 125a, container / carrier plates 150a, 151a, syringe removal tool 170a, and syringe rack 142a are included herein.

[0017] 1B, measurement system 100b may include measurement device 105b in communication with remote device (e.g., server) 125b via network 135b. Measurement device 105b may be similar to measurement device 105a of FIG. 1A, for example. Remote device 125b may be similar to remote device 125a of FIG. 1A, for example.

[0018] The system 100b may implement communication between the measurement device 105b and a remote device 125b (eg, a remote server) to, for example, provide syringe data and / or desired measurement data to a digital image-based measurement database 127b.

[0019] For example, system 100b may obtain syringe data and / or desired measurement data, for example, from a user of measurement device 105b (e.g., a digital image-based measurement device, etc.). Alternatively or in addition, not shown in FIG. 1B, syringe data and / or desired measurement data may be obtained automatically from a third party data source (e.g., syringe manufacture, drug manufacturer, etc.). As detailed herein, system 100b may automatically determine the depth of a plunger in at least one syringe, etc.

[0020] For clarity, only one measuring device 105b is shown in FIG. 1B. Although FIG. 1B shows only one measuring device 105b, it should be understood that any number of measuring devices 105b may be supported, and each measuring device 105b may be any suitable digital image-based measuring device. The measuring device 105b may include a corresponding memory 122b and a processor 124b for storing and executing a module 123b. The module 123b stored in the memory 122b as a set of computer readable instructions may relate to an application for automatically determining a plunger depth in at least one syringe.

[0021] As described in more detail herein, the modules 123b may facilitate interactions between the associated measurement device 105b and the remote device 125b. For example, the processor 124b may further execute the modules 123b to facilitate communications between the remote device 125b and the measurement device 105b via the measurement device network interface 115b, the measurement device communication link 136b, the network 135b, the remote device communication link 137b, and the remote device network interface 133b.

[0022] The measurement device 105b may include a user interface 111b, which may be any type of electronic display device, such as a touch screen display, a liquid crystal display (LCD), a light emitting diode (LED) display, a plasma display, a cathode ray tube (CRT) display, or any other type of known or suitable electronic display, along with a user input device. The user interface 111b may present a user interface (e.g., any of the user interfaces 120, 127a, 120c, 127c, 120d, 127f, etc.) that presents a user interface for configuring the measurement device 105b to communicate with a remote device 125b.

[0023] The network interface 133b may be configured to facilitate communication between the measurement device 105b and the remote device 125b via any wireless communication network 135b, including, for example, a wireless LAN, a MAN or WAN, WiFi, the Internet, or any combination thereof. Furthermore, the measurement device 105b may be communicatively connected to the remote device 125b via any suitable communication system, including those using wireless communication structures such as wireless communication networks, including, for example, wireless LANs and WANs, satellite and cellular telephone communication systems, and the like. The measurement device 105b may transmit or store, for example, projectile and / or stabilizer related data in, for example, the remote device 125b, the memory 130b, and / or the remote digital image-based measurement database 127b.

[0024] The remote device 125b may include a user interface 126b, a memory 130b, and a processor 132b for storing and executing, respectively, a module 131b. The module 131b, stored in the memory 132b as a set of computer readable instructions, may facilitate applications related to automatically determining plunger depth in at least one syringe. The module 131b may also facilitate communication between the remote device 125b and the measurement device 105b via a network interface 133b and a network 135b, as well as other functions and instructions.

[0025] The remote device 125b may be communicatively coupled to a digital image-based metrology database 127b. Although the digital image-based metrology database 127b is shown in FIG. 1B as being communicatively coupled to the remote device 125b, it should be understood that the digital image-based metrology database 127b may be located in a separate remote server (or any other suitable computing device) that is communicatively coupled to the remote device 125b. Optionally, portions of the digital image-based metrology database 127b may be associated with memory modules that are separate from one another, such as the memory 122b of the measurement device 105b.

[0026] Referring to FIG. 1C, an automatic imager 100c may include a frame 109c and an imaging system. The measuring device 105c may be similar to, for example, the measuring device 105a of FIG. 1A or the measuring device 105b of FIG. 1B. In some embodiments, the imaging system may be movable relative to the frame 109c, or the imaging system may be fixed on the frame 109c. Additionally, in the embodiment of FIG. 1C, the automatic imager 105c may be designed to operate on a desktop or workbench. However, in some embodiments, the automatic imager 105c may be a larger laboratory device.

[0027] The imaging system 100c may include a camera 106c and an illumination source, as well as an imaging surface 108c and an illumination source. In the embodiment of FIG. 1C, the imaging surface 108c may be disposed between the camera 106c and the illumination source. As shown, the camera 106c may be disposed above the imaging surface 108c, and the illumination source may be disposed below the imaging surface 108c. The camera 106c and the illumination source may be any camera and illumination source known in the art. For example, the camera 106c may be a mirrored or non-mirrored, analog or digital sensor of any resolution, and the like. In addition, the illumination source may be any known light source, including at least one light emitting diode (LED), incandescent light bulb, fluorescent, light redirected by a mirror, and the like. The imaging surface 108c may be transparent to allow light from the illumination source to be received by the camera 106c. The imaging surface 108c may be, for example, any plastic, ceramic, glass, or other transparent material.

[0028] The imaging system may be disposed on the frame 109c. The frame 109c of the automatic imager 105c may include a base 116c, a head, and a support arm. As shown, the base 116c and the head may be vertically separated. In this embodiment, the base 116c may include the input system 111c, and the head may include the display 110c. However, the input system 111c and the display 110c may be disposed on either the base 116c or the head. Alternatively, the input system 111c and the display 110c may be separate from the frame 109c. For example, the input system 111c may include the keyboard 114a and the mouse 113a, and the display 110c may include the monitor 126a. In still further embodiments, the display 110a and the input system 111c may be combined together as a touch screen display.

[0029] As shown, the head may be disposed on a support arm 109c above a base 116c. The support arm 109c may keep the head disposed vertically above the base 116c, but in some embodiments, the head may be adjustable along the height of the support arm 109c. Thus, the head may be either fixed relative to the base 116c or movable relative to the base 116c. Additionally, in some embodiments, the head may include a controller or processor (e.g., processor 125b in FIG. 1B), although the processor 124b may be located outside the automatic imager 100c. The processor 124b may be configured to receive image data from the camera 106c and further include a communication unit for transmitting and receiving data to and from a network (e.g., network 135b in FIG. 1B).

[0030] In operation, the automated imager 100c may be activated by a user, for example, via user controls 111c. When preparing to generate image data, the processor 124b may activate an illumination source disposed on the base 116c and below the imaging surface 108c. The user may then place an object to be imaged, such as the container 150a of the syringe 140a, on the imaging surface 108c. Using the input system 111c, the user may generate image data by taking a picture via the camera 106c. After the image data is generated, the display 110c may present the picture 120c taken via the camera 106c, as well as other measured metrics 127c. In some embodiments, the picture 120c and the measured metrics 127c are presented on the display 110c and then transmitted to the network 135c, for example, via the network connection 115e. Such secure transmission of pictures and / or measured metrics to the network 135c may also be accompanied by, for example, a batch number for tracking and recording data related to syringe manufacturing quality. The network 135c may be connected to a local data server, a remote data server 125a, or other cloud storage solutions.

[0031] 1D and 1E, a measurement system 100d,e may include a measurement device 105d,e, and may further include a digital camera 106d,e, a target orientation sensor 107d,e, an imaging surface 108d,e having at least one alignment feature 117d,e, a support structure 109e, a display device 110d,e having multiple user interface displays 120d,e, a user control panel 111d,e, manual imaging surface / camera orientation / focus controls 112d, a network connection 115e, and a base 116e. The user control panel 111d,e may include a power on button 101d, a power on indicator 102d, a measurement / image orientation control 103d, a print button 104d, a measurement OK indicator 118d, and a measurement NG indicator 119d.

[0032] 1F, the remote device 125f may include a display device 126f having a plurality of user interfaces 127f, a keyboard 128f, a mouse 129f, and a printer 134f. The measuring devices 105a-e may be configured to automatically determine a plunger depth of a plunger in at least one syringe, for example, in response to a user placing the at least one syringe 140a on the imaging surface 108a. Alternatively or in addition, the measuring devices 105a-e may be configured to automatically determine a plunger depth of a plunger in at least one syringe, for example, in response to a user placing the at least one syringe 140a on the imaging surface 108a and activating the measurement control 103d or the print button 104d. More desirably, the measuring devices 105a-e may be configured to automatically determine a plunger depth of a plunger in a corresponding one of the plurality of syringes, for example.

[0033] Although not shown in Figures 1A-1F, the syringe removal tool 170a may be fixed to (or connectable to), for example, a robotically controlled syringe transfer machine configured to remove multiple syringes from a container, position the multiple syringes on an imaging surface of a measuring device, and return the multiple syringes to the container after the measuring machine determines a corresponding plunger depth for each syringe and electronically records / displays / prints the associated plunger depth measurement results.

[0034] 2A, a syringe alignment rack assembly 200a may include a syringe rack 241a having a plurality of syringe receptacles 243a, 245a. Each syringe receptacle 243a, 245a may be configured to align a corresponding syringe 244a, 246a with respect to the syringe rack 241a in a predetermined orientation. The syringe rack assembly 200a may also include at least one rack alignment feature 242a configured to align the rack 241a with the syringe plunger depth measurement device 105a. The plurality of syringe receptacles 243a, 245a may be linearly arranged along the length of the rack 241a. The plurality of syringe receptacles 243a, 245a may be configured to hold the plurality of syringes 244a, 246a side-by-side such that the needle ends of every other one of the plurality of syringes 244a, 246a face toward a first side of the rack 241a. The needle ends of other syringes of the plurality of syringes 244a, 246a may face toward a second side of the rack 241a. Although the syringe alignment rack assembly 200a may be shown in FIG. 1A as including twenty syringe receptacles 243a, 245a, the syringe alignment rack assembly 200a may include any number of syringe receptacles 243a, 245a.

[0035] The syringe alignment rack assembly 200a may include at least one handle portion 247a. As shown, the syringe alignment rack assembly 200a may include a handle portion 247a at each end of the syringe alignment rack assembly 200a. In either case, the handle portion 247a may extend upward and outward at an angle from an upper surface of the syringe alignment rack assembly 200a for easy handling, for example. The syringe alignment rack assembly 200a may further include at least one visible rack alignment marker 248a configured to provide an alignment reference for, for example, the measurement devices 105a-e. Alternatively or in addition, the measurement devices 105a-e may be configured to detect an edge of the syringe alignment rack assembly 200a (e.g., an edge of the syringe alignment rack assembly 200a along a first side, an edge of the syringe alignment rack assembly 200a along a second side, etc.).

[0036] 2B, the syringe alignment rack assembly 200b may include a syringe rack 241b having a plurality of syringe receptacles 243b. Each syringe receptacle 243b may be configured to align a corresponding syringe 244b with respect to the syringe rack 241b in a predetermined orientation. The syringe rack assembly 200b may also include at least one rack alignment feature 242b configured to align the rack 241b with the syringe plunger depth measurement device 105a. The plurality of syringe receptacles 243b may be linearly arranged along the length of the rack 241b. The plurality of syringe receptacles 243b may be configured to hold the plurality of syringes 244b side-by-side with the needle ends of the plurality of syringes 244b facing toward a first side of the rack 241b. Although the syringe alignment rack assembly 200b may be shown in FIG. 1B as including eighteen syringe receptacles 243b, the syringe alignment rack assembly 200b may include any number of syringe receptacles 243b.

[0037] The syringe alignment rack assembly 200b may include at least one handle portion 247a. As shown, the syringe alignment rack assembly 200b may include a handle portion 247b at each end of the syringe alignment rack assembly 200b. In either case, the handle portion 247b may extend upward and outward at an angle from an upper surface of the syringe alignment rack assembly 200b, for example, for easy handling. The syringe alignment rack assembly 200b may further include at least one visible rack alignment marker 248b, for example, configured to provide an alignment reference for the measurement devices 105a-e. Alternatively or in addition, the measurement devices 105a-e may be configured to detect an edge of the syringe alignment rack assembly 200b (e.g., an edge of the syringe alignment rack assembly 200b along a first side, an edge of the syringe alignment rack assembly 200b along a second side, etc.).

[0038] 2C, syringe alignment rack 200c may resemble either a portion of syringe alignment rack 200a or a portion of syringe alignment rack 200b. In either case, syringe receptacles 243a, 245a, 243b may include an open end 245c that may define, for example, a syringe barrel receptacle 243c configured to receive syringe barrel 252c. A bottom surface (e.g., bottom surface 814 in FIGS. 4B and 4C) of flange end 246c of syringe 244c may rest on the periphery of open end 245c (i.e., similar to the relationship of bottom surface 814 to corresponding syringe receptacle 473c as shown in FIG. 4C). Syringe receptacles 243a, 245a, 243b may also include syringe alignment tabs 248c that may be configured, for example, to engage distal ends 249e of corresponding syringe barrels 252c.

[0039] Syringe receptacles 243a, 245a, 243b may further include closed ends that may define, for example, capped needle receptacles 250c configured to receive capped needle ends 251c of syringes 244c. As shown, capped needle receptacles 250c may be shorter than barrel receptacles 243c (e.g., the length of barrel receptacles 243c may be based on the length of corresponding syringe barrels 252c; the length of capped needle receptacles 250c may be based on the length of corresponding capped needle ends 251c, etc.).

[0040] Syringe barrel receptacle 243c may include curved sides 247c that may, for example, conform to a portion of a peripheral surface of an associated syringe barrel 244c. As shown, a portion of the barrel receptacle between curved sides 247c may be open, for example, to allow a camera of measurement device 105a-e (e.g., cameras 105a-e of FIGS. 1A-1E) to image at least a portion of the length of syringe barrel 252c and plunger 253c that is back-illuminated via a backlight source (e.g., backlight source 156a of FIG. 1A).

[0041] The syringe rack assemblies 200a-c may be at least partially made of plastic, rubber, or the like. In at least one embodiment, the syringe rack assemblies 200a-c are made of a material that does not result in any metal-glass contact between the syringe rack assemblies 200a-c and the corresponding syringes and / or cartridges. The predetermined measurement tolerance (e.g., a measurement accuracy tolerance associated with a plunger depth measurement relative to a syringe) may be, for example, the sum of a syringe-to-rack alignment tolerance, a rack-to-imaging device alignment tolerance, and a measurement device (e.g., measurement devices 105a-e of FIGS. 1A-1E). In at least one embodiment, the sum of the syringe-to-rack alignment tolerance, the rack-to-imaging device alignment tolerance, and the measurement device 105a-e alignment tolerance is less than the predetermined measurement tolerance.

[0042] 3A and 3B, the syringe transport assembly 300a,b may include a container 350a configured to accommodate a plurality of syringes 352a. The syringe transport assembly 300a,b may also include a syringe carrier plate 351a having a plurality of apertures extending from a top surface of the syringe carrier plate to a bottom surface of the syringe carrier plate. Each of the plurality of syringes 352a may be linearly inserted into a corresponding one of the plurality of apertures, for example. The syringe transport assembly 300a,b may further include a container insert 353b configured to be placed in the container 350a before the plurality of syringes 352a are placed in the container 350a, and the container insert 353b may include at least one syringe elevator 355b linearly aligned with at least one of the plurality of syringes 352a. When syringe carrier plate 351a and multiple syringes 352a are placed in container 350a, at least one syringe linearly aligned on at least one syringe elevator 355b can be linearly elevated relative to the remaining syringes of multiple syringes 352a.

[0043] The apertures in the syringe carrier plate 351a may be arranged in rows and columns. The container insert 353b may include two syringe elevators 355b. A first one of the syringe elevators may be aligned with a first row of the apertures. A second one of the syringe elevators 355b may be aligned with a second row of the apertures. The container insert 353b may include an upper lip, and the upper lip 354b is configured to align the syringe carrier plate 351a with the container 350a when the periphery of the syringe carrier plate 351a is received within the upper lip 354b. Although the syringe transport assembly 300a,b may be shown in FIGS. 3A and 3B as including a 10×10 array of syringes 352a, the syringe transport assembly 300a,b may include any number of syringes 352a. In at least one embodiment, the number of syringes 352a aligned in syringe elevator 355b is equal to or less than the number of syringe receptacles (e.g., syringe receptacle 473a in FIG. 4A) of an associated syringe removal tool (e.g., syringe removal tool 470a in FIG. 4A).

[0044] 4A, the syringe extraction tool 470a may include a syringe carrier 477a having a first end, a second end, and a plurality of syringe receptacles 473a arranged linearly along an edge of the syringe carrier 477a extending from the first end to the second end. In FIG. 4A, the syringe extraction tool may be shown as including ten syringe receptacles 473a, but the syringe extraction tool may include any number of syringe receptacles 473a. In at least one embodiment, the number of syringe receptacles 473a is equal to or greater than the number of associated syringes (e.g., syringe 352a in FIG. 3A) aligned with the syringe elevator (e.g., syringe elevator 355b in FIG. 3B).

[0045] The syringe removal tool 470a may be configured to remove a plurality of syringes 152a from the container 150a. The syringe removal tool 470a may also include a stationary gripper 471a having a first end and a second end. A first end of the syringe carrier 477a may be connected to a first end of the stationary gripper 471a via a first sliding rod 476a. A second end of the syringe carrier 471a may be connected to a second end of the stationary gripper 471a via a second sliding rod 476a. The syringe retainer portion 475a may include a first end, a second end, and a plurality of spring-biased syringe retainers 478a / 479a linearly arranged along the syringe retainer portion 475a from the first end to the second end. Each spring biased syringe retainer 478a may be configured to retain a corresponding syringe in a corresponding syringe receptacle 473a independent of any other spring biased syringe retainer 478a in the plurality of spring biased syringe retainers 478a. A first end of the syringe retainer portion 475a may be configured to slide along a first sliding rod 476a. A first end of the syringe retainer portion 475a may be biased toward a first end of the syringe carrier portion 477a via a first syringe retainer portion biasing spring 474a. A second end of the syringe retainer portion 475a may be configured to slide along a second sliding rod 476a. A second end of syringe retainer portion 475a may be biased toward a second end of syringe carrier portion 477a via second syringe retainer portion biasing spring 474a. Syringe carrier portion 477a and plurality of syringe retainers 478a may be at least partially made of plastic, rubber, or the like. In at least one embodiment, syringe carrier portion 477a and plurality of syringe retainers 478a may include a non-metallic surface (e.g., a plastic surface, a rubber surface, a nylon surface, etc.) that contacts each of the plurality of syringes (e.g., a glass surface, etc.).

[0046] Tool 470a may also include at least one tool alignment feature 471a1, 471a2 configured to align tool 470a to syringe plunger depth measurement device 105a (e.g., alignment feature 471a1 may engage tool alignment feature 117a or alignment feature 582a of FIG. 5A). The predetermined measurement tolerance (e.g., measurement accuracy tolerance associated with plunger depth measurement relative to the syringe) may be, for example, the sum of an alignment tolerance of the syringe-to-syringe extraction tool, an alignment tolerance of the syringe extraction tool-to-imaging device, and a tolerance of a measurement device (e.g., measurement devices 105a-e of FIGS. 1A-1E). In at least one embodiment, the sum of the alignment tolerance of the syringe-to-syringe extraction tool, an alignment tolerance of the syringe extraction tool-to-imaging device, and a tolerance of a measurement device 105a-e is less than the predetermined measurement tolerance.

[0047] 4B, measurement system 400b is shown to include a portion of syringe retainer portion 475b (e.g., a portion of syringe retainer portion 475a of FIG. 4A) proximate to a syringe (e.g., syringe 802 of FIG. 7E). As described with reference to FIG. 4A, syringe retainer portion 475a,b may include a first end, a second end, and a plurality of spring-biased syringe retainers 478a / 479a linearly arranged along syringe retainer portion 475a from the first end to the second end. Each spring-biased syringe retainer 478a may be configured to retain a corresponding syringe in a corresponding syringe receptacle 473a independent of any other spring-biased syringe retainers 478a in the plurality of spring-biased syringe retainers 478a. A first end of the syringe retainer portion 475a may be configured to slide along the first sliding rod 476a. The first end of the syringe retainer portion 475a may be biased toward the first end of the syringe carrier portion 477a via the first syringe retainer portion biasing spring 474a. A second end of the syringe retainer portion 475a may be configured to slide along the second sliding rod 476a. The second end of the syringe retainer portion 475a may be biased toward the second end of the syringe carrier portion 477a via the second syringe retainer portion biasing spring 474a. The syringe carrier portion 477a and the plurality of syringe retainers 478a may be at least partially made of plastic, rubber, or the like. In at least one embodiment, the syringe carrier portion 477a and the plurality of syringe retainers 478a may include a non-metallic surface (e.g., a plastic surface, a rubber surface, a nylon surface, etc.) that contacts each of the plurality of syringes (e.g., a glass surface, etc.).

[0048] As further shown in FIG. 4B (as well as FIG. 7E), the syringe 404 may include a needle cap 310 covering a needle (not shown), a syringe barrel 312, a plunger 314, a medicament 316, a bubble 318, and a flange 810. The syringe barrel 312 may be transparent or translucent. Typically, the needle may be coupled to the syringe barrel 312 at a needle hub. The needle hub may include, for example, a syringe shoulder integrally formed with the barrel 312 and directly coupled to the needle (forming what is commonly referred to as a "stake needle"), a luer lock type connector, and / or any other mechanism for directly or indirectly coupling the syringe to the needle. The flange 810 is disposed at a proximal end of the syringe 802 opposite the needle and the needle cap 310. The flange 810 includes a proximal end 814 and a distal end 812. 7E, plunger 314 may include a proximal end 822 and a distal end 824, with distal end 824 closest to flange 810. Flange 810 may include a lower surface 814.

[0049] 4C, measurement system 400c may include syringe receptacle 473c (e.g., similar to a portion of syringe receptacle 473b of FIG. 4B), spring-biased syringe retainer 478c (e.g., similar to a portion of spring-biased syringe retainer 478b / 479b of FIG. 4B), syringe retaining portion 475c (e.g., similar to a portion of syringe retaining portions 475a, b of FIGS. 4A and 4B), and a portion of a syringe (e.g., a portion of syringe 404 of FIGS. 4B and 7E). In any case, lower surface 810 of syringe flange 810 may be biased toward an upper surface of syringe receptacle 473c, for example, via corresponding spring-biased syringe retainer 478c. The spring-biased syringe retainer may include a syringe flange contact portion 478c, a sliding rod 479c3, a biasing spring 479c2, and a fastener 479c1. The biasing spring 479c2 may be configured to bias the syringe flange contact portion 478c toward an upper surface of the syringe receptacle 473c, thereby securing the syringe 404 to the syringe receptacle 473c. Correspondingly, the sliding rod 479c3 may slide within the aperture 475c1 to the syringe holding portion 475c. A lower surface of the spring-biased syringe retainer 478c may include a non-metallic surface (e.g., a plastic surface, a nylon surface, a rubber surface, etc.).

[0050] 4D, measurement system 400d may include syringe removal tool 202 in operative relationship with container 204 of syringes. For quality control, container 204 containing multiple syringes 210 may be provided for evaluation. In some embodiments, each syringe of multiple syringes 210 in container 204 needs to be evaluated. In other embodiments, only a subset of multiple syringes 210 needs to be evaluated. For example, a user may only need to remove a row of syringes 212a or fill a single syringe 212b. In total, container 204 may contain more than 160 syringes.

[0051] 4E-4F, measurement systems 400e-f and methods may include a user (e.g., a lab technician, a syringe manufacturer, etc.) handling a plurality of syringes 300 in accordance with the present disclosure. As shown, each of the plurality of syringes 300 includes a needle disposed within a needle cap 310, a syringe barrel 312, a plunger 314, a medication 316, and an air bubble 318. In accordance with the present disclosure, a person (e.g., a lab technician, a manufacturer) may vibrate 330 the plurality of syringes 300 to move the air bubble 318 within each syringe closer to the needle and needle cap 310 within the syringe barrel 312.

[0052] As shown in Figure 4E, measurement system 400e may include a syringe 402 having an air bubble 318 proximate to the needle and needle cap 310. In contrast, the air bubble 318 in syringe 404 may be located proximate to the plunger 314. After vibration 330, measurement system 400f can detect the air bubble 318 in each syringe 402 and 404, which is located proximate to the needle cap 310, and the medication 316 is located proximate to the plunger 314, as shown in Figure 4F.

[0053] 5, the syringe and measurement device alignment assembly 500 may include an alignment adapter 580. The alignment adapter 580 may include at least one measurement device alignment feature 581 configured to engage, for example, with an alignment feature of the measurement device 105a (e.g., alignment feature 117a of FIG. 1A). The alignment adapter 580 may also include at least one syringe rack alignment feature 582 configured to engage, for example, with an alignment feature of the syringe racks 241a,b (e.g., alignment features 242a,b of FIGS. 2A and 2B, respectively). The syringe and measurement device alignment assembly 500 may be configured to align, for example, the syringe racks 241a,b or a syringe removal tool (e.g., syringe removal tool 170a of FIG. 1A) to a camera (e.g., camera 106a of FIG. 1A) in a predetermined orientation relative to one another.

[0054] 6A and 6B, a plurality of syringes 300 are positioned on an imaging surface 108c of the automated imager 100c of FIG. 1C. As shown in FIG. 6A and 6B, the imaging surface 108c includes a leading edge 612, a trailing edge 614, and a side edge 616. The plurality of syringes 300 (e.g., syringes similar to, for example, syringe 152a of FIG. 1A) may be generally centered on the imaging surface 114 (e.g., an imaging surface similar to, for example, imaging surface 108a of FIG. 1A), although the plurality of syringes 300 can be positioned anywhere on the imaging surface 114 that is within the field of view of the camera 110 (e.g., a camera similar to camera 106a of FIG. 1A). As shown, the plurality of syringes 300 are positioned in a single row parallel to the imaging surface 114 and the leading edge 612. In some embodiments, multiple syringes may be placed in the syringe housing aligned with respect to the imaging surface 114 with the aid of alignment mechanism 630. Alignment feature 630 may be secured to frame 102 via fasteners 710a and 710b, may be integrally formed with imaging surface 114 or base 122, or may be coupled to imaging system 104 by any other known method.

[0055] Referring to FIG. 7A, a side view of the alignment of a syringe relative to the camera 110 is shown. In some embodiments, the imaging system 104 may be sensitive to the rotational angle 1210 of the syringe barrel 312 relative to the camera 110. For example, the syringe barrel 312 may include a flat portion 1220 that affects the light captured by the camera 110 after passing through the syringe barrel 312. In such embodiments, it may be preferable for the flat portion 1220 to be positioned perpendicular to the camera 110. In the embodiment of FIG. 7A, the flat portion 1220 is perpendicular to the camera when the syringe barrel 312 is at 0, 180, or 360 degrees (°). As shown in FIG. 7A, it can be seen that the syringe 1232a is perpendicular to the camera and is at 0° or 360°, while the syringe 1232b is at 45°.

[0056] Thus, the camera 110 may only be able to obtain an accurate picture of the syringe 1232a if the camera 110 is sensitive to the angle of the syringe barrel 312. Thus, in some embodiments, if multiple syringes 300 are placed on the imaging surface 114, each of the syringes 300 may need to be rotated to align with the camera 110. However, some cameras 110 and imaging systems 104 are able to take accurate pictures regardless of the angle of the syringes 1232a and 1232b.

[0057] 7B, an exemplary display 130 (e.g., a display similar to display 110a of FIG. 1A) is shown presenting a picture 142 of measured plunger depth metrics 144 of a plurality of syringes 300. As shown in the exemplary display 130, a first syringe 902 has a plunger depth measurement 910 of 10.52 millimeters (mm). The plunger depth measurement is shown in the measured metrics 144 in a first column 912. Thus, each syringe of the plurality of syringes shown in the picture 142 corresponds to a column in the measured metrics 144 presented on the exemplary display 130.

[0058] In accordance with the present disclosure, processor 132 processes picture 142 to measure plunger depth 910. Because the distance between camera 110 and imaging surface 114 is known, the processor can accurately measure the distance in the image. In addition, processor 132 can measure plunger depth 910 of each syringe in picture 142. In some embodiments, after processor 132 measures plunger depth 910 for the proximal end of a given drug syringe, processor 132 verifies that plunger depth 910 is correct (e.g., within a predetermined tolerance) for the given drug.

[0059] 7C, an exemplary display is shown in which a first syringe 1002 has a correct plunger depth measurement 1006 and a second syringe 1012 has an incorrect plunger depth measurement 1016. As shown, the plunger depth measurement 1006 is based on a correct identification of the proximal end 820 of the plunger 314. As a result, the plunger depth measurement 1006 correctly measures the distance from the proximal end of the flange (not shown) to the proximal end 820 of the plunger 314. In contrast, the plunger depth measurement 1016 incorrectly measures the distance between the proximal end of the flange (not shown) and the edge of the air bubble 318.

[0060] 7D, an exemplary method 1100 of syringe plunger insertion and equilibration is shown. In a first step 1102, the syringe is filled with a drug 316. In a second step 1110, the syringe barrel 312 and drug 316 are exposed to a reduced pressure 1112. In some embodiments, the reduced pressure 1112 can be a vacuum or a near vacuum condition. As a result, at the end of the second step 1110, a portion 1114 of the syringe barrel 312 is exposed to reduced air pressure.

[0061] In a third step 1120, a rod 1122 inserts the plunger 314 into the barrel 312 of the syringe. The plunger 314 is inserted into the barrel 312 while the barrel 312 is still exposed to reduced pressure 1112 conditions, possibly a vacuum or near vacuum pressure. While the plunger 314 is inserted, the syringe barrel may contain a re-pressurized cavity 1114 due to liquid evaporation in the reduced pressure 1112.

[0062] In a fourth step 1130, the syringe barrel 312 is again exposed to normal atmospheric conditions 1132. Such conditions may cause the plunger 314 to move further into the syringe barrel 312. The plunger 314 may continue to be pushed further into the syringe barrel 312 until a fifth step 1140, at which point the pressure 1142 around the plunger 314 eventually equalizes. As shown in the fifth step 1140, the pressure 1142 on either side of the plunger 314 is approximately atmospheric pressure. However, in some embodiments, frictional forces may cause a small pressure difference between the cavity 1114 and atmospheric pressure. The syringe may then be returned to the container in a sixth step 1150 for subsequent testing.

[0063] 7E, a side view of a plunger depth measurement 800. As shown, an exemplary syringe 802, which is substantially identical to syringe 402 and syringe 404, includes a needle and needle cap 310, a syringe barrel 312, a plunger 314, a medicament 316, a gas bubble 318, and a flange 810. The flange 810 is disposed at a proximal end of the syringe 802, opposite the needle and needle cap 310. The flange 810 includes a proximal end 814 and a distal end 812. Similarly, as shown in FIG. 7E, the plunger 314 also includes a proximal end 820 and a distal end 822, with the proximal end 820 closest to the flange 810.

[0064] In accordance with the present disclosure, the plunger depth measurement 800 is measured as the distance between the proximal end 812 of the flange 810 and the proximal end 820 of the plunger 314. The measurement 800 excludes any bumps 824 or irregular protrusions formed during the manufacturing process and disposed on the proximal end 820 of the plunger 314. The plunger depth measurement 800 is unique to each pharmaceutical product, container, and fill volume. As a result, the plunger depth measurement 800 aids in quality verification of the manufactured product.

[0065] 8A, the measurement device 805a may include a user interface generating module 881a, a syringe data receiving module 882a, a desired measurement data receiving module 883a, an image data receiving module 884a, a manual image orientation / focus data receiving module 885a, a plunger location data determining module 887a, a measurement input receiving module 886a, a print measurement input receiving module 888a, and a measurement data transmitting module 889a, which may be stored in memory 822a, for example, as a set of computer readable instructions. In any event, modules 881a-889a may be similar to module 123b of FIG. 1B, for example.

[0066] Referring to Figure 8B, a method of operating a measuring device 800b may be implemented by a first processor (e.g., processor 124b of measuring device 105b of Figure 1B) executing, for example, at least a portion of modules 881a-889a of Figure 8A and / or by a second processor (e.g., processor 132b of remote device 125b of Figure 1B) executing, for example, at least a portion of modules 991b-996b of Figure 9B. In particular, processor 124b may execute user interface generation module 881a to cause processor 124b to generate, for example, user interfaces 120a, 127a, 120c, 127c, 120d, 127f (block 881b).

[0067] The processor 124b may execute a syringe data receiving module 882a, for example, causing the processor 124b to receive desired measurement data from, for example, a remote device (block 883b). The processor 124b may execute a desired measurement data receiving module 883a, for example, causing the processor 124b to receive image data (e.g., real-time image data) from, for example, the camera 106a (block 884b). The processor 124b may execute a manual image orientation / focus data receiving module 885a, for example, causing the processor 124b to receive manual image orientation / focus data from a user via the user input devices 111a, 112a (block 885b). The processor 124b may execute a measurement input receiving module 886a to cause the processor 124b to receive measurement data from a user, for example, via the user input 111a (block 886b).

[0068] The processor 124b may execute a plunger location data determination module 887a to cause the processor 124b to determine plunger location data based on, for example, digital image data (block 887b). The processor 124b may execute a print measurement input receiving module 888a to cause the processor 124b to receive printed measurement data from a user, for example, via the user interface 111a (block 888b). The processor 124b may execute a measurement data transmission module 889a to cause the processor 124b to transmit measurement data to, for example, a remote device (block 889b).

[0069] 9A, the remote device 925a may include a user interface generation module 991a, a syringe data receiving module 992a, a desired measurement data receiving module 993a, a desired measurement data transmitting module 994a, a measurement data receiving module 995a, and a measurement data analysis module 996a, which may be stored in memory 930a, for example, as a set of computer readable instructions. In any case, modules 1810d-1830d may be similar to, for example, module 1898a of FIG. 18A.

[0070] 9B, a method of operating a measuring device 800b may be implemented by a first processor (e.g., processor 124b of measuring device 105b of FIG. 1B) that executes, for example, at least a portion of modules 881a-889a of FIG. 8A and / or by a second processor (e.g., processor 132b of remote device 125b of FIG. 1B) that executes, for example, at least a portion of modules 991b-996b of FIG. 9B. In particular, processor 132b may execute user interface generation module 991a to cause processor 132b to generate, for example, user interfaces 120a, 127b, 120c, 127d, 127f (block 991b).

[0071] The processor 132b may execute a syringe data receiving module 992a to cause the processor 132b to receive syringe data from a user, for example, via a user interface (block 992b). The processor 132b may execute a desired measurement data receiving module 993a to cause the processor 132b to receive desired measurement data from a user, for example, via a user interface (block 993b).

[0072] The processor 132b may execute a desired measurement data transmission module 994a, for example, causing the processor 132b to transmit desired measurement data to a measurement device (block 994b). The processor 132b may execute a measurement data reception module 995a, for example, causing the processor 132b to receive measurement data from a measurement device (block 995b). The processor 132b may execute a measurement data analysis module 996a, for example, causing the processor 132b to analyze the measurement data (block 996b).

[0073] The above description describes various devices, assemblies, components, subsystems, and methods for use in conjunction with drug delivery devices, such as pre-filled syringes. The devices, assemblies, components, subsystems, methods, or drug delivery devices (i.e., pre-filled syringes) may further include or be used with drugs, including but not limited to the drugs identified below, and their generic and biosimilar equivalents. As used herein, the term drug may be used interchangeably with other similar terms and may be used to refer to any type of drug or therapeutic material, including traditional and non-traditional drugs, nutraceuticals, supplements, biologics, biologically active agents and compositions, large molecules, biosimilars, bioequivalents, therapeutic antibodies, polypeptides, proteins, small molecules, and generic drugs. Non-therapeutic injectable materials are also included. Drugs may be in liquid form, lyophilized form, or reconstituted from lyophilized form. The following list of exemplary drugs should not be considered exhaustive or limiting.

[0074] The drug will be contained in a reservoir, for example, in a pre-filled syringe. In some cases, the reservoir is a primary container into which the drug is either filled or pre-filled for treatment. The primary container may be a vial, a cartridge, or a pre-filled syringe.

[0075] In some embodiments, the reservoir of the drug delivery device may be loaded with or the device may be used with colony stimulating factors such as granulocyte colony stimulating factor (G-CSF). Such G-CSF formulations include, but are not limited to, Neulasta® (pegfilgrastim, PEGylated filgrastim, 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).

[0076] In other embodiments, the drug delivery device may contain or be used with an erythropoietin stimulating agent (ESA), which may be in liquid or lyophilized form. An ESA is any molecule that stimulates erythropoietin. In some embodiments, an ESA is an erythropoietin stimulating protein. As used herein, "erythropoietin stimulating protein" refers to any protein that directly or indirectly causes activation of the erythropoietin receptor, for example, by binding to the receptor and causing receptor dimerization. Erythropoietin stimulating proteins include erythropoietin and its variants, analogs or derivatives that bind to and activate the erythropoietin receptor; antibodies that bind to and activate the erythropoietin receptor; or peptides that bind to and activate the erythropoietin receptor. Erythropoietin stimulating proteins include Epogen® (epoetin alfa), Aranesp® (darbepoetin alfa), Dynepo® (epoetin delta), Mircera® (methoxypolyethylene 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 and molecules or variants or analogs thereof.

[0077] Among the specific exemplary proteins are the specific proteins described below, including fusions, fragments, analogs, variants or derivatives thereof: OPGL-specific antibodies (also referred to as RANKL-specific antibodies, peptibodies, etc.), peptibodies, related proteins, etc., including fully humanized and human OPGL-specific antibodies, particularly fully humanized monoclonal antibodies; myostatin-binding proteins, peptibodies, related proteins, etc., including myostatin-specific peptibodies; and proteins that specifically bind to the receptors for IL-4 and / or IL-13. interleukin 1-receptor 1 ("IL1-R1") specific antibodies, peptibodies, related proteins, etc.; Ang2 specific antibodies, peptibodies, related proteins, etc.; NGF specific antibodies, peptibodies, related proteins, etc.; CD22 specific antibodies, peptibodies, related proteins, etc., particularly the dimerization of human-mouse monoclonal hLL2 gamma chain disulfide bound to human-mouse monoclonal hLL2 kappa chain, which inhibits activity mediated by the binding of human CD22-specific 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 the human CD22-specific fully humanized antibody epratuzumab (CAS Registry No. 501423-23-0); IGF-1 receptor-specific antibodies, peptibodies and related proteins, including but not limited to anti-IGF-1R antibodies; B7RP-specific fully human monoclonal IgG B-7 related protein 1 specific antibodies, peptibodies, related proteins and the like (also referred to as "B7RP-1" and B7H2, ICOSL, B7h and CD275), including but not limited to fully human IgG2 monoclonal antibodies that bind to 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, particularly humanized monoclonal antibodies, such as 145c7, including but not limited to HuMax IL-15 antibodies and related proteins;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, as well as 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; fully human monoclonal antibodies that neutralize hepatocyte growth factor / scatter factor (HGF / SF) 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 monoclonal antibodies; 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; and proteins that bind to c-Kit and / or other stem cell factor receptors, including, but not limited to, including, but not limited to, c-Kit specific antibodies, peptibodies, related proteins, etc.; OX40L specific antibodies, peptibodies, related proteins, etc., including, but not limited to, proteins that bind OX40L and / or other ligands of the OX40 receptor; Activase® (alteplase, tPA); Aranesp® (darbepoetin alfa), erythropoietin [30-asparagine, 32-threonine, 87-valine, 88-asparagine, 90-threonine], darbepoetin alfa, a new erythropoiesis stimulating transcription factor (ERT) inhibitor. protein (NESP); Epogen® (epoetin alfa or erythropoietin); GLP-1, Avonex® (interferon beta-1a); Bexxar® (tositumomab, an anti-CD22 monoclonal antibody); Betaseron® (interferon-beta); Campath® (alemtuzumab, an anti-CD52 monoclonal antibody); Dynepo® (epoetin delta); Velcade® (bortezomib); MLN0002 (anti-α4β7 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, a biosimilar of Herceptin® or another product containing trastuzumab for the treatment of breast or gastric cancer; Humatrope® (somatropin, human growth hormone); Humira® (adalimumab); Vectibix (registered trademark (panitumumab), Xgeva® (denosumab), Prolia® (denosumab), immunoglobulin G2 human monoclonal antibody against 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); Kineret® (anakinra); Leukine® (sargamostim, rhuGM-CSF); LymphoCide® (epratuzumab, anti-CD22 mAb); Benlysta™ (lymphostat B, belimumab, anti-BlyS mAb); Metalyse® (tenecteplase, t-PA analog); Mircera® (methoxypolyethylene glycol-epoetin beta); Mylotarg® (gemtuzumab ozogamicin); Raptiva® (efalizumab); Cimzia® (certolizumab pegol, CDP 870); Soliris™ (eculizumab); pexelizumab (anti-complement C5); Numax® (MEDI-524); Lucentis® (ranibizumab);Panorex® (17-1A, edrecolomab); Trabio® (lerdelimumab); TheraCim hR3 (nimotuzumab); Omnitarg (pertuzumab, 2C4); Osidem® (IDM-1); OvaRex® (B43.13); Nuvion® (vigilizumab); cantuzumab mertansine (huC242-DM1); NeoRecormon® (epoetin beta); Neumega® (oprelvekin, human interleukin-11); Orthoclone OKT3® (muromonab-CD3, anti-CD3 monoclonal antibody); Procrit® (epoetin alpha); Remicade® (infliximab, anti-TNFα monoclonal antibody); Reopro® (abciximab, anti-GP lIb / Ilia receptor monoclonal antibody; Actemra® (anti-IL6 receptor mAb); Avastin® (bevacizumab), HuMax-CD4 (zanolimumab); Mvasi™ (bevacizumab-awwb); Rituxan® (rituximab, anti-CD20 mAb);Tarceva® (erlotinib);Roferon-A®-(interferon alpha-2a);Simulect® (basiliximab);Prexige® (lumiracoxib);Synagis® (palivizumab);145c7-CHO (anti-IL15 antibody, see U.S. Pat. No. 7,153,507);Tysabri® (natalizumab, anti-α4 integrin mAb);Valortim® (MDX-1303, anti-B. anthracis protective antigen mAb);ABthrax®;Xolair® (omalizumab);ETI211 (anti-MRSA mAb);IL-1 trap (Fc portion of human IgG1 and extracellular domain of both IL-1 receptor components (type I receptor and receptor accessory protein));VEGF trap (IgG1 Ig domain of VEGFR1 fused to Fc; Zenapax® (daclizumab); Zenapax® (daclizumab, an anti-IL-2Rα mAb);Zevalin® (ibritumomab tiuxetan); Zetia® (ezetimibe); Orencia® (atacicept, TACI-Ig); anti-CD80 monoclonal antibody (galiximab); anti-CD23 mAb (lumiliximab); BR2-Fc (huBR3 / huFc fusion protein, soluble BAFF antagonist); CNTO 148 (golimumab, anti-TNFα mAb); HGS-ETR1 (mapatuzumab; human anti-TRAIL receptor-1 mAb); HuMax-CD20 (ocrelizumab, anti-CD20 human mAb); HuMax-EGFR (zalutumumab); M200 (volociximab, anti-α5β1 integrin mAb); MDX-010 (ipilimumab, anti-CTLA-4 mAb and VEGFR-1 (IMC-18F1); anti-BR3 mAbs; anti-C. difficile toxin A and toxin BC 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 stage 1 fibrogen (FG-3019); anti-CTLA4 mAb; anti-eotaxin 1 mAb (CAT-213); anti-FGF8 mAb; anti-ganglioside GD2 mAb;Anti-ganglioside GM2 mAb;Anti-GDF-8 human mAb (MYO-029);Anti-GM-CSF receptor mAb (CAM-3001);Anti-HepC mAb (HuMax HepC);Anti-IFNα mAb (MEDI-545, MDX-198);Anti-IGF1R mAb;Anti-IGF-1R mAb (HuMax-Inflam);Anti-IL12 mAb (ABT-874); anti-IL12 / IL23 mAb (CNTO 1275); anti-IL13 mAb (CAT-354); anti-IL2Ra mAb (HuMax-TAC); anti-IL5 receptor mAb; anti-integrin receptor mAb (MDX-018, CNTO 95);Anti-IP10 ulcerative colitis mAb (MDX-1100);BMS-66513;Anti-mannose receptor / hCGβ mAb (MDX-1307); anti-mesothelin dsFv-PE38 conjugate (CAT-5001); anti-PD1 mAb (MDX-1106 (ONO-4538)); anti-PDGFRα antibody (IMC-3G3); anti-TGFβ mAb (GC-1008); anti-TRAIL receptor-2 human mAb (HGS-ETR2); anti-TWEAK mAb; anti-VEGFR / F; lt-1 mAb; and anti-ZP3 mAb (HuMax-ZP3).

[0078] In some embodiments, the drug delivery device may contain or be used in conjunction with a sclerostin antibody, such as, but not limited to, romosozumab, brosozumab, BPS 804 (Novartis), Evenity™ (romosozumab-aqqg), another product containing romosozumab for the treatment of postmenopausal osteoporosis and / or fracture healing, and in other embodiments, a monoclonal antibody (IgG) that binds to 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 in conjunction with rilotumumab, bixalomer, trebananib, ganitumab, conatumumab, motesanib niphosphate, brodalumab, vidupiprant, or panitumumab. In some embodiments, the reservoir of the drug delivery device may be loaded with, or the device may be used with, IMLYGIC® (talimogene laherparepvec) or another oncolytic HSV for the treatment of melanoma or other cancers, including but not limited to OncoVEXGALV / CD; OrienX010; G207, 1716; NV1020; NV12023; NV1034; and NV1042. In some embodiments, the drug delivery device may contain, or be used with, an endogenous tissue inhibitor of metalloproteinases (TIMP), 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 product containing erenumab for the treatment of migraine. Antagonistic antibodies to the human calcitonin gene-related peptide (CGRP) receptor, such as, but not limited to, erenumab, and bispecific antibody molecules targeting the CGRP receptor and other headache targets, may also be delivered using the drug delivery devices of the present disclosure.In addition, bispecific T cell engager (BiTE®) antibodies, 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 an analogue thereof. In some embodiments, a therapeutically effective amount of anti-thymic stromal lymphopoietin (TSLP) or a 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 Avsola™ (infliximab-axxq), an anti-TNF alpha monoclonal antibody, a biosimilar of 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 in conjunction 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 in conjunction with Otezla® (apremilast), N-[2-[(1S)-1-(3-ethoxy-4-methoxyphenyl)-2-(methylsulfonyl)ethyl]-2,3-dihydro-1,3-dioxo-1H-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 Parsabiv™ (etelcalcetide HCl, KAI-4169) or another product containing etelcalcetide HCl 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 of 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 the Fc domain of IgG1). In some embodiments, the drug delivery device may contain or be used with ABP 959 (eculizumab), a biosimilar candidate of Soliris®, or another product containing a monoclonal antibody that specifically binds to complement protein C5. In some embodiments, the drug delivery device may contain or be used with rogivafusp alfa (formerly AMG 570), 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 omecamtib mecarbil, a small molecule selective cardiac myosin activator, or myotrope, that directly targets the contractile machinery of the heart, or another product containing a small molecule selective cardiac myosin activator. In some embodiments, the drug delivery device may contain sotorasib (formerly known as AMG 510), a KRAS. G12C Small molecule inhibitors, or KRAS G12CIt may contain or be used with another product containing a small molecule inhibitor. In some embodiments, the drug delivery device may contain or be used with another product containing tezepelumab, a human monoclonal antibody that inhibits the action of thymic stromal lymphopoietin (TSLP), or a human monoclonal antibody that inhibits the action of TSLP. In some embodiments, the drug delivery device may contain or be used with another product containing AMG 714, a human monoclonal antibody that binds to interleukin-15 (IL-15), or a human monoclonal antibody that binds to interleukin-15 (IL-15). In some embodiments, the drug delivery device may contain or be used with another product containing AMG 890, a small interfering RNA (siRNA) that reduces lipoprotein (a), also known as Lp(a), or a small interfering RNA (siRNA) that reduces lipoprotein (a). In some embodiments, the drug delivery device may contain or be used with ABP 654 (human IgG1 kappa antibody), a biosimilar candidate of Stelara®, or another product that contains a human IgG1 kappa antibody and / or binds to the p40 subunit of the human cytokines interleukin (IL)-12 and IL-23. In some embodiments, the drug delivery device may contain or be used with Amjevita™ or Amgevita™ (formerly ABP 501) (mab anti-TNF human IgG1), a biosimilar candidate of Humira®, or another product that contains a human mab anti-TNF human IgG1. 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, the drug delivery device may contain or be used in conjunction with another product containing AMG 119 or delta-like ligand 3 (DLL3) CAR T (chimeric antigen receptor T cell) cell therapy.In some embodiments, the drug delivery device may contain or be used with another product containing AMG 119, or a delta-like ligand 3 (DLL3) CAR T (chimeric antigen receptor T cell) cell therapy. In some embodiments, the drug delivery device may contain or be used with another product containing AMG 133, or a gastric inhibitory polypeptide receptor (GIPR) antagonist and a GLP-1R agonist. In some embodiments, the drug delivery device may contain or be used with another product containing AMG 171, or a growth differentiation factor 15 (GDF15) analog. In some embodiments, the drug delivery device may contain or be used with another product containing AMG 176, or 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 a 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 activate 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 in conjunction 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 multispecific FAPx4-1BB targeted DARPin® biologic being investigated 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 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) CD19xCD3 BiTE® (bispecific T cell engager) construct. In some embodiments, the drug delivery device may contain efavalukin alfa (formerly known as efavarukin alfa). In some embodiments, the drug delivery device may contain or be used with another product containing AMG 592 or an IL-2 mutein Fc fusion protein. In some embodiments, the drug delivery device may contain or be used with another product containing AMG 596 or a CD3 x epidermal growth factor receptor vIII (EGFRvIII) BiTE® (bispecific T cell engager) molecule. In some embodiments, the drug delivery device may contain or be used with another product containing AMG 673 or 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 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 in conjunction 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 in conjunction with AMG 910 or another product containing a half-life extended (HLE) epithelial cell tight junction component protein claudin 18.2 x CD3 BiTE® (bispecific T cell engager) construct.

[0079] The drug delivery devices, assemblies, components, subsystems, and methods have been described in terms of exemplary embodiments, but are not limited thereto. The detailed description should be construed as merely exemplary and does not describe all possible embodiments of the present disclosure. Many alternative embodiments can be implemented using either current technology or technology developed after the filing date of this patent, and such embodiments still fall within the scope of the claims that define the invention disclosed herein.

[0080] Those skilled in the art will understand that numerous modifications, alterations, and combinations can be made to the above-described embodiments without departing from the spirit and scope of the invention disclosed herein, and such modifications, alterations, and combinations are to be construed as falling within the scope of the inventive concept.

Claims

1. Providing an imaging system including an imaging surface and a processor; aligning a syringe on the imaging surface with respect to the imaging system, the syringe having a transparent or translucent syringe barrel including a distal end and a proximal end, and a plunger disposed within the syringe barrel at a plunger depth relative to the distal end of the syringe barrel; capturing an image of the syringe including the plunger and a proximal end of the syringe; measuring said plunger depth via said processor; determining, via said processor, whether said plunger depth is within a predetermined tolerance; A rapid syringe quality verification method, including:

2. The method of claim 1 , wherein the imaging system comprises a digital light comparator and / or the image includes an illuminated shadow.

3. (a) the syringe further includes a flange disposed at a distal end of the syringe; or 2. The method of claim 1, wherein the syringe further comprises a flange disposed at a distal end of the syringe, the plunger comprises a distal end and a proximal end opposite the distal end, the flange comprises a distal end and a proximal end opposite the distal end, and the plunger depth is measured as the distance between the distal end of the flange and the distal end of the plunger.

4. Aligning a flat portion of the syringe barrel with respect to the imaging system; and / or The method of any one of claims 1 to 3, further comprising generating syringe quality data and storing the syringe quality data.

5. providing an alignment device carrying a plurality of syringes, each syringe including a transparent or translucent syringe barrel having a distal end and a proximal end, a plunger disposed within the syringe barrel; providing an imaging system including an imaging surface having at least one alignment tab; placing the alignment device and the plurality of syringes on the imaging surface against the at least one alignment tab; capturing an image of the alignment device and an image of the plurality of syringes via a camera; measuring, via a processor, a plunger depth of each plunger disposed within each of the plurality of syringes relative to the distal end of the syringe barrel; determining, via said processor, whether said plunger depth for each plunger is within a predetermined tolerance; A method for analyzing a plurality of syringes, comprising:

6. the imaging system comprises a digital optical comparator; and / or The method of analyzing a plurality of syringes of claim 5 , wherein the image includes an illuminated shadow of each syringe.

7. (a) each plunger includes a distal end and a proximal end opposite the distal end; or 7. The method of claim 5 or 6, wherein (b) each plunger includes a distal end and a proximal end opposite the distal end, each syringe further includes a flange disposed at the distal end of the syringe, each flange including a distal end and a proximal end opposite the distal end, and each plunger depth is measured as the distance between the distal end of a corresponding flange and the distal end of a corresponding plunger.

8. Aligning a flat portion of each syringe barrel with the imaging system; and / or 7. The method of analyzing a plurality of syringes of claim 5 or 6, further comprising generating syringe quality data and storing the syringe quality data.

9. an imaging system capable of generating imaging data, the imaging system including a camera, an imaging surface, and an illumination source; an alignment device for aligning at least one syringe with respect to the imaging system; a processor configured to receive the imaging data from the imaging system and determine whether a plunger depth within a barrel of the at least one syringe is within a predetermined tolerance; An automated syringe measuring system comprising:

10. The automated syringe measurement system of claim 9 , further comprising an alignment tab disposed on the imaging surface and configured to align the alignment device with respect to the imaging system.

11. the imaging system comprises a digital optical comparator; and / or The automated syringe measurement system of claim 9 or 10, wherein the imaging data generated by the imaging system includes an illuminated shadow image of the at least one syringe.

12. The automated syringe measurement system of claim 9 or 10, wherein the imaging surface is disposed between the camera and the illumination source.

13. The alignment device comprising: a spring-activated mechanism for holding the at least one syringe; and / or The automated syringe measuring system of claim 9 or 10, wherein the alignment device is configured to hold between 8 and 25 syringes.

14. 11. The automated syringe measurement system of claim 9 or 10, wherein the processor is further configured to transmit at least one of the imaging data and the plunger depth to an external memory.

15. 1. A syringe carrying container assembly, said assembly comprising: a container configured to house a plurality of syringes; a syringe carrier plate having a plurality of apertures extending from a top surface of the syringe carrier plate to a bottom surface of the syringe carrier plate, each of the plurality of apertures configured to receive one of a plurality of syringes; a container insert configured to be placed in the container before the plurality of syringes are placed in the container, the container insert including at least one syringe elevator aligned with at least one of the plurality of syringes, the at least one syringe elevator configured to elevate the at least one syringe configured to be received in the at least one aperture aligned with the syringe elevator relative to the remaining syringes of the plurality of syringes when the syringe carrier plate, the container insert, and the plurality of syringes are placed in the container; An assembly comprising:

16. (a) the plurality of apertures in the syringe carrier plate are arranged in a plurality of rows and a plurality of columns, and the container insert includes two syringe elevators, a first syringe elevator aligned with a first column of the plurality of apertures and a second syringe elevator aligned with a second column of the plurality of apertures; or 16. The assembly of claim 15, wherein (b) the container insert includes an upper lip configured to align the syringe carrier plate with the container when a periphery of the syringe carrier plate is received within the upper lip.

17. 1. A syringe carrying container assembly, said assembly comprising: a container configured to house a plurality of syringes, the container including at least one syringe elevator aligned with at least one of the plurality of syringes; a syringe carrier plate having a plurality of apertures extending from a top surface of the syringe carrier plate to a bottom surface of the syringe carrier plate, each of the plurality of apertures configured to accommodate a corresponding one of the plurality of syringes, and wherein when the syringe carrier plate and the plurality of syringes are disposed within the receptacle, the at least one syringe elevator is configured to elevate the at least one syringe configured to be accommodated within the aperture aligned with the syringe elevator relative to the remaining syringes of the plurality of syringes; An assembly comprising: (a) the plurality of apertures in the syringe carrier plate are arranged in a plurality of rows and a plurality of columns; or (b) the plurality of apertures in the syringe carrier plate are arranged in a plurality of rows and a plurality of columns, and the container includes two syringe elevators, a first one of the syringe elevators being aligned with a first column of the plurality of apertures and a second one of the syringe elevators being aligned with a second column of the plurality of apertures; or 18. The assembly of claim 17, wherein (c) the plurality of apertures in the syringe carrier plate are arranged in a plurality of rows and a plurality of columns, the container includes two syringe elevators, a first syringe elevator aligned with a first row of the plurality of apertures and a second one of the syringe elevators aligned with a second row of the plurality of apertures, and the upper lip is configured to align the syringe carrier plate with the container when a periphery of the syringe carrier plate is received within the upper lip.

19. 1. A syringe removal tool, comprising: a syringe carrier having a first end, a second end, and a plurality of syringe receptacles linearly arranged along an edge of the syringe carrier from the first end to the second end; a stationary gripper having a first end and a second end, the first end of the syringe carrier being connected to the first end of the stationary gripper via a first slide rod and the second end of the syringe carrier being connected to the second end of the stationary gripper via a second slide rod; a syringe retainer portion having a first end, a second end, and a plurality of spring-biased syringe retainers linearly arranged along the syringe retainer portion from the first end to the second end, each spring-biased syringe retainer configured to retain a corresponding syringe in a corresponding syringe receptacle independent of any other spring-biased syringe retainer in the plurality of spring-biased syringe retainers; the first end of the syringe retainer portion is configured to slide along the first slide rod, and the first end of the syringe retainer portion is biased toward the first end of the syringe carrier via a first syringe retainer portion biasing spring; the second end of the syringe retainer portion is configured to slide along the second slide rod; The second end of the syringe retainer portion is biased toward the second end of the syringe carrier via the second syringe retainer portion biasing spring.

20. (a) the syringe carrier and the plurality of syringe retainers include non-metallic surfaces in contact with the plurality of syringes; or 20. The tool of claim 19, wherein (b) at least one of the spring-biased syringe retainers includes a syringe holding portion, a syringe flange contact portion, a sliding rod, a biasing spring, and a fastener, the biasing spring configured to bias the syringe flange contact portion toward an upper surface of a corresponding syringe receptacle, and further wherein the syringe is secured to the syringe receptacle.

21. 1. A syringe rack comprising a plurality of syringe receptacles, at least one of the syringe receptacles including an open end defining a syringe barrel receptacle configured to receive a syringe barrel, each syringe receptacle configured to align a corresponding syringe in a predetermined orientation relative to the syringe rack, the syringe rack comprising at least one rack alignment feature configured to align the rack to a syringe plunger depth measurement device.

22. the plurality of syringe receptacles are linearly arranged along a length of the rack; and (a) the syringe receptacles are configured to hold the syringes side-by-side with needle ends of the syringes facing toward a first side of the rack; or 22. The rack of claim 21, wherein (b) the plurality of syringe receptacles are configured to hold the plurality of syringes side-by-side such that every other needle end of the plurality of syringes is directed toward a first side of the rack and other needle ends of the plurality of syringes are directed toward a second side of the rack.

23. (a) At least one syringe barrel receptacle includes curved sides, the curved sides being configured to fit over a portion of a periphery of an associated syringe barrel; or 23. The rack of claim 21 or 22, wherein (b) a portion of the syringe barrel receptacle between the curved sides is open to allow a camera of a measurement device to image at least a portion of the length of the syringe barrel and plunger that is illuminated from behind via a backlight source.