Systems, devices, and methods for measuring components

Abstract

Systems for measuring a drug container closure member such as a syringe stopper and related methods and devices are disclosed. A system for measuring a drug container closure member may include a measurement device configured to measure at least one characteristic of the drug container closure member. The system may further include a positioning device or fixture having a base and an arm configured to extend from the base. Furthermore, the arm may be configured to hold the drug container closure member in at least one position allowing the measurement device to measure the at least one characteristic of the drug container closure member.

Description

10675-W001-SECSYSTEMS, DEVICES, AND METHODS FOR MEASURING COMPONENTSCROSS-REFERENCE TO RELATED APPLICATION(S)

[0001] Priority is claimed to United States Provisional Patent Application No. 63 / 703,567, filed October 4, 2024, the entire contents of which are hereby incorporated by reference herein.FIELD OF DISCLOSURE

[0002] The present disclosure generally relates to measurement systems, devices, and methods, and, more particularly, systems, devices, and methods for measuring one or more components of a drug delivery device.BACKGROUND

[0003] Accurate and consistent measurement of a component is in many cases required to ensure product quality and safety in the pharmaceutical, medical device, and various other industries. Among such components, drug container closure members, including, for example, syringe and drug cartridge stoppers, may maintain the sterility and integrity of a drug stored in a container and therefore may need to satisfy strict tolerance requirements. These closure members are often made of an elastomeric material and may be designed to form a tight seal to prevent contamination and / or leakage of the drug. Given their essential function, the dimensional accuracy of drug container closure members in many cases must be carefully monitored and controlled during the manufacturing process.

[0004] Verifying the dimensions of a drug container closure member may require multiple, high-precision measurements of the component, and, in at least some instances, may require an unobstructed view of one or more sides of the drug container closure member during the measurement process. A challenge in using existing measurement instruments and processes is the need to hold and stabilize the drug container closure member securely in an elevated position without deforming or altering its dimensions. The elastomeric materials typically used to construct drug container close members complicate this task as they may be prone to deform. Moreover, assessing multiple drug container closure members in rapid succession can be inefficient or cumbersome when performed with existing measurement instruments and processes, particularly when the instrument requires operation by a person. Further still, manual or makeshift setups for holding the drug container closure member may lead to inconsistent measurements and / or fail to properly account for the specific geometries of particular drug container closure members.

[0005] To address one or one of the needs and challenges mentioned herein and other related needs and challenges, the present disclosure sets forth advantageous systems, devices, and methods for measuring or facilitating the measurement of drug container closure members and / or other components.SUMMARY

[0006] One aspect of the present disclosure provides a system for measuring a drug container closure member and / or other component(s). The system may include a measurement device configured to measure at least one characteristic of the drug container closure member. The system may further include a positioning device having a base and an arm. The arm may be configured to extend from the base and hold the drug container closure member in at least one position allowing the measurement device to measure the at least one characteristic of the drug container closure member.

[0007] Another aspect of the present disclosure provides method including: (a) providing a measurement device configured to measure at least one characteristic of a drug container closure member and / or other component(s); (b) providing a positioning device comprising a base and a first arm configured to extend from the base; (c) removably coupling a drug container closure member to a first arm; and (d) positioning the first arm to allow the measurement device to measure the at least one characteristic of the drug container closure member.

[0008] An additional aspect of the present disclosure provides a positioning device for use in measuring a drug container closure member and / or other component(s). The positioning device may include a base and an arm. The arm may be10675-W001-SEC configured to extend from the base and hold the drug container closure member in at least one position allowing measurement of at least one characteristic of the drug container closure member.BRIEF DESCRIPTION OF THE DRAWINGS

[0009] It is believed that the disclosure will be more fully understood from the following description taken in conjunction with the accompanying drawings. Some of the drawings may have been simplified by the omission of selected elements for the purpose of more clearly showing other elements. Such omissions of elements in some drawings are not necessarily indicative of the presence or absence of particular elements in any of the exemplary embodiments, except as may be explicitly delineated in the corresponding written description. Also, none of the drawings is necessarily drawn to scale.

[0010] Fig. 1 is a perspective view of a drug delivery device in accordance with various embodiments.

[0011] Fig. 2 illustrates a perspective view of a drug container closure member in accordance with various embodiments.

[0012] Fig. 3 depicts a schematic view of a measurement system in accordance with various embodiments.

[0013] Fig. 4 illustrates a perspective view of a positioning device in accordance with various embodiments.

[0014] Fig. 5 illustrates a partially exploded assembly view of the positioning device in Fig. 4.

[0015] Fig. 6 is a perspective view of an arm of the positioning device illustrated in Figs. 4 and 5.

[0016] Fig. 7 is a side view of the arm in Fig. 6.

[0017] Fig. 8 is a perspective view of another embodiment of an arm for use with the positioning device shown in Figs. 4 and 5.

[0018] Fig. 9 is a side view of the arm in Fig. 8.DETAILED DESCRIPTION

[0019] The present disclosure generally pertains to systems, devices, and methods for measuring or assisting in the measurement of one or more characteristics of drug container closure members and / or other components including, for example, medical device and / or drug delivery device related components. The drug container closure member can take various forms including, for example, a stopper for a prefilled syringe or other syringe, a stopper for a drug cartridge, or another component for sealing a drug container. The disclosed embodiments enable precise, repeatable measurements of drug container closure members using automated measurement devices including, for example, Keyence® measurement devices, as well as semiautomatic and manual measurement systems. The disclosed embodiments may be configured to hold a drug container closure member stably and securely during the measurement process, without deforming or altering the dimensions of the drug container closure member. This may improve the overall accuracy of dimensional, positional, surface, and / or other measurements and contribute to the efficient production of high-quality drug container closure members. Furthermore, the disclosed embodiments are capable of accommodating standard and specific geometries, sizes, etc. of various drug container closure members, making them useful across a variety of contexts. Additionally, the disclosed embodiments simplify the process of mounting a drug container closure in an elevated or other desirable position for measurement, which helps streamline the process of verifying the dimensions and other characteristics of the drug container closure member. Furthermore, the disclosed approach may be beneficial for in-process inspections, allowing early detection of deviations from specifications and thus reducing the potential for producing a defective product. These and other advantages will be apparent to one of ordinary skill in the art reviewing the present disclosure.

[0020] To provide context for the various embodiments of the measurement systems, devices, and methods described further below, a non-limiting example of a drug container closure member will be described with reference to Figs. 1 and 2. While the present examples of the drug container closure member generally take the form of a stopper for a prefilled syringe, the systems, devices, and methods of the present disclosure are not limited to the measurement of syringe stoppers and may be used to measure other components including, for example, stoppers and other sealing members for use in a drug container lacking an integrated needle.10675-W001-SEC

[0021] Fig. 1 illustrates a syringe 10 for injecting a drug, which may also be referred to herein as a medicament or drug product, into tissue of a patient. The drug may be, but is not limited to, various biologies such as peptides, peptibodies, and / or antibodies. The drug may be in a fluid or liquid form, gelatin form, powdered form, and / or any other suitable form.

[0022] The syringe 10 may include a drug container 12 (depicted as generally transparent in Fig. 1), a plunger or plunger rod 14, a drug container closure member 16, and a needle 18. The drug container 12 may have a longitudinal axis A1 and a proximal end 12a and a distal end 12b arranged along the longitudinal axis A1. The drug container 12 may include a barrel 24 having a generally cylindrical wall 26 at least partially defining an internal bore or reservoir 28. The wall 26 of the barrel 24 may be made of a rigid or semi-rigid material including, for example, glass, plastic (e.g., polypropylene), and / or any other suitable material or combination of materials. At least a portion of, or the entirety of, the barrel 24 may have cross-sectional shape (e.g., in a plane perpendicular to the longitudinal axis A1) that is generally circular or any other suitable shape.

[0023] The plunger 14 may extend through a proximal axial opening 27 in the proximal end 12a of the drug container 12 such that a distal end 14b of the plunger 14 is disposed at least partially within the drug container 12 and a proximal end 14a of the plunger 14 is disposed at least partially outside of the drug container 12. Generally, the plunger 14 may be configured to allow a user of the syringe 10 to manually or semi-manually move the drug container closure member 16 in a distal direction and / or a proximal direction along the longitudinal axis A1. As an example, the plunger 14 may have a longitudinal axis A2 that is parallel to and / or coaxial with the longitudinal axis A1 of the drug container 12. As a more specific example, the proximal end 14a of the plunger 14 may include a thumb rest 40 allowing a user to press his or her thumb against a proximally facing surface of the thumb rest 40 to push the plunger 14, and thereby the drug container closure member 16, in the distal direction along the longitudinal axis A1 to expel the drug from the reservoir 28 through the needle 18 into, for example, the patient’s tissue.

[0024] The drug container closure member 16 may be referred to in at least some contexts as a stopper or a syringe stopper. The drug container closure member 16 may be movably disposed within the drug container 12 such that when a distally directed force is applied to the drug container closure member 16, for example, by the plunger 14, the drug container closure member 16 moves in the distal direction along the longitudinal axis A1 to expel the drug in the reservoir 28 of the drug container 12 out through the needle 18. Proximal movement of the drug container closure member 16 along the longitudinal axis A1 may also be possible in at least some configurations. The drug container closure member 16 may slidably and / or sealingly contact an interior surface of the wall 26 of the barrel 24 such that, for example, the drug in the reservoir 28 is prevented or inhibited from leaking past the drug container closure member 16 when the drug container closure member 16 moves in the distal direction, as well as prior to and / or after such movement. As an example, the drug container closure member 16 may form a fluid-tight seal with the interior surface of the wall 26 of the barrel 24. In alternative embodiments, including, for example, certain of those where the drug delivery device is a drug cartridge instead of a syringe, the drug container closure member 16 may be fixedly coupled with a wall of the drug container, such that the drug container closure member 16 does not move relatively to the wall of the drug container during operation.

[0025] The drug container closure member 16 may be constructed of any suitable material or combination of materials which facilitate the sealing, sliding, and / or other function(s) of the drug container closure member 16. In some embodiments, the drug container closure member 16 may be made, partially or entirely, of an elastomeric material such as rubber, including, for example, butyl rubber, chlorobutyl rubber, bromobutyl rubber, and / or silicone rubber. In some embodiments, the drug container closure member 16 may be coated with a thin layer of silicone to reduce friction and facilitate smooth movement of the drug container closure member 16 through the drug container 12.

[0026] As illustrated in Fig. 2, the drug container closure member 16 may have a generally cylindrical or other elongate shape extending along a longitudinal axis A3. In some embodiments, the longitudinal axis A3 of the drug container closure member 16 may be parallel to and / or coaxial with the longitudinal axis A1 of the drug container 12 and / or the longitudinal axis A2 of the plunger 14 when, for example, the drug container closure member 16 is disposed within the drug container 12 and / or coupled10675-W001-SEC with the plunger 14. Furthermore, the drug container closure member 16 may include a proximal end 16a and a distal end 16b arranged along the longitudinal axis A3. The proximal end 16a of the drug container closure member 16 may include a proximal axial opening 17 communicating with an internal cavity 19 of the drug container closure member 16. The internal cavity 19 may be closed off by the distal end 16b of the drug container closure member 16. In some embodiments, the distal end 14b of the plunger 14 may be inserted into the internal cavity 19 in order to couple the plunger 14 with the drug container closure member 16. This coupling may be permanent or removable. In some embodiments, an interior surface of the drug container closure member 16 and an exterior surface of the distal end 14b of the plunger 14 each may be threaded, such that these components can be threadably coupled with each other. In other embodiments, the plunger 14 may not be inserted into the internal cavity 19 of the drug container closure member 16, instead pushing on a proximally facing end surface of the drug container closure member 16 during operation.

[0027] The drug container closure member 16 may include one or more radially outwardly extending protrusions or ribs configured to sealingly and / or slidably engage the interior surface of the drug container 12. As an example, as seen in Figs. 1 and 2, the drug container closure member 16 may include annular protrusions 23a-d arranged at various axial positions along the longitudinal axis A3 of the drug container closure member 16.

[0028] The dimensions of the drug container closure member 16 may, in some embodiments, depend on the size or volume of the drug container 12 given that the drug container closure member 16, or at least a portion thereof, may need to fit snugly inside of the drug container 16. In some embodiments, an outer diameter D1 of the drug container closure member 16 may be less than or equal to approximately (e.g., ±10%) 30 mm, or less than or equal to approximately (e.g., ±10%) 25 mm, or less than or equal to approximately (e.g., ±10%) 20 mm, or less than or equal to approximately (e.g., ±10%) 15 mm, or less than or equal to approximately (e.g., ±10%) 10 mm, or less than or equal to approximately (e.g., ±10%) 5 mm, or within a range between approximately (e.g., ±10%) 25-29 mm, or within a range between approximately (e.g., ±10%) 17-21 mm, or within a range between approximately (e.g., ±10%) 12-16 mm, or within a range between approximately (e.g., ±10%) 9-13 mm, or within a range between approximately (e.g., ±10%) 7-11 mm, or within a range between approximately (e.g., ±10%) 3-7 mm. In some embodiments, a length L1 of the drug container closure member 16 may be less than or equal to approximately (e.g., ±10%) 20 mm, or less than or equal to approximately (e.g., ±10%) 15 mm, or less than or equal to approximately (e.g., ±10%) 10 mm, or less than or equal to approximately (e.g., ±10%) 5 mm, or within a range between approximately (e.g., ±10%) 15-20 mm, or within a range between approximately (e.g., ±10%) 10-12 mm, or within a range between approximately (e.g., ±10%) 8-10 mm, or within a range between approximately (e.g., ±10%) 7-9 mm, or within a range between approximately (e.g., ±10%) 6-8 mm, or within a range between approximately (e.g., ±10%) 4-5 mm.

[0029] In a storage state, the drug container 12 may be filled partially or entirely with a drug, or may be empty. In some embodiments, the drug container 12 may be prefilled with a drug, for example, by a manufacturer and / or other supplier, and shipped to the point-of-care ready or substantially ready for operation by the user. In certain such embodiments, the syringe 10 may to take the form of a prefilled syringe. In other embodiments, the syringe 10 may be provided to the user empty and the user may be required to fill the drug container 12 at the point-of-care, for example, by transferring the drug from a vial or other external drug storage container into the syringe 10 immediately or substantially immediately before operating the syringe 10 to perform an injection.

[0030] In some embodiments, a volume of the drug disposed in the drug container 12 of the syringe 10 may be equal to 0.5 mL, or equal to approximately (e.g., ±10%) 0.5 mL, or equal to 1 mL, or equal to approximately (e.g., ±10%) 1 mL, or equal to 2.25 mL, or equal to approximately (e.g., ±10%) 2.25 mL, or equal to 3 mL, or equal to approximately (e.g., ±10%) 3 mL, or less than or equal to approximately (e.g., ±10%) 1 mL, or less than or equal to approximately (e.g., ±10%) 2 mL, or less than or equal to approximately (e.g., ±10%) 3 mL, or less than or equal to approximately (e.g., ±10%) 4 mL, or less than approximately (e.g., ±10%) 5 mL, or less than or equal to approximately (e.g., ±10%) 10 mL, or within a range between approximately (e.g., ±10%)10675-W001-SEC0.5 - 10 mL, or within a range between approximately (e.g., ±10%) 0.5 - 5 mL, or within a range between approximately (e.g., ±10%) 0.5 - 4 mL, or within a range between approximately (e.g., ±10%) 0.5 - 3 mL, or within a range between approximately (e.g., ±10%) 0.5 - 2.25 mL.

[0031] In some embodiments, the needle 18 may be fixedly coupled with the distal end 12b of the drug container 12 and / or in fluid communication with the reservoir 28. A proximal end of the needle 18 may be adhered, staked, or otherwise rigidly mechanically connected to, or integrally formed with, the wall 26 of the barrel 24 such that the needle 18 cannot move with respect to (i.e., relative to) the wall 26 of the barrel 24. A distal end 21 of the needle 18 may include a sharpened tip or other pointed geometry allowing the distal end 21 of the needle 18 to pierce and / or penetrate through a patient’s skin, subcutaneous tissue, and / or other tissue of the patient. The needle 18 may be hollow and / or include an axial passage that is parallel to and / or coaxial with the longitudinal axis A of the drug container 12. One or more openings may be formed in the distal end 21 of the needle 18 to allow drug to flow out of the needle 18 into the patient during operation of the syringe 10. The needle 18 may be made of metal, plastic, and / or any other suitably rigid material. Prior to use, the distal end of the needle 18 may be covered with a removable sterile barrier (not shown in Fig. 1) such as, for example, a rigid needle shield (RNS) or a non-rigid needle shield (nRNS). The removable sterile barrier may be configured to protect the needle 18 from contaminants in an external or ambient environment prior to operation of the syringe 10. The patient or user may be required to remove the removable sterile barrier from the needle 18 prior to operating the syringe 10 to perform a drug injection. In alternative embodiments, the needle 18 may be omitted or at least not initially coupled with the drug container 12. In such alternative embodiments, the distal end 12b of the drug container 12 may be coupled with and / or form a nozzle or other fluid path member including, for example, a male or female Luer Lock fitting.

[0032] Fig. 3 illustrates an embodiment of a system 100 for measuring a drug container closure member including, for example, the drug container closure member 16 described above or a variant thereof. Generally, the system 100 may be configured to hold the drug container closure member 16 in one or more positions and measure one or more characteristics of the drug container closure member 16. The system 100 may include various device(s) and / or subsystem(s) coupled with each other to achieve some or all of these functionalities and / or other(s). In some embodiments, the system 100 may include, for example, any one or combination of a measurement device 110 and a positioning device 112. In some embodiments, the positioning device 112 may be a separate or add-on device which may be removably coupled with the measurement device 110, for instance, when it is necessary or desirable to use the measurement device 110 to measure a drug container closure member. In certain such embodiments, the positioning device 112 may be configured so that it can be used interchangeably among various measurement devices, including different types or brands of measurement devices. In other embodiments, the positioning device 112 may be integrated into (e.g., permanently coupled with) the measurement device 110.

[0033] As illustrated in Fig. 3, the measurement device 110 may be a freestanding device configured for placement on a support surface 114, which may be a tabletop, benchtop, the ground, or any other surface. Generally, the measurement device 110 may be configured for non-contact and / or contact measurements of a wide range of objects, components, etc. to assist in dimensional analysis, inspection, quality control, and / or other activities in manufacturing, industrial, laboratory, clinical, hospital, and / or other settings. In some embodiments, the measurement device 110 may be a Keyence® measurement device or a similar such device. In some embodiments, the measurement device 110 may have micro-level accuracy and repeatability, which may facilitate measurements of, for example, components subject to strict dimensional tolerances.

[0034] The measurement device 110 may be configured to measure, for example, any one or combination of the following characteristics of an object, including, for example, a drug container closure member: dimension(s) of the object (e.g., length, width, height, thickness, depth, diameter, etc.), position(s) of the object (e.g., vertical position(s), horizontal position(s), rotational position(s), orientation(s), elevation(s), alignment(s), angle(s), inclination(s), displacement(s), distance(s) from a reference, etc.), and surface characteristic(s) of the object (e.g., surface roughness, texture, flatness, coating thickness, cracks, warping, surface10675-W001-SEC irregularities, etc.). Additionally or alternatively, the measurement device 110 may be configured to measure, for example, any one or combination of the following: optical characteristic(s) (e.g., transparency, reflectivity, color, refractive index, etc.), mechanical characteristic(s) (e.g., weight), electrical characteristic(s) (e.g., electrical conductivity, electrical resistance, electrical capacitance, magnetism, etc.), chemical characteristic(s) (e.g., corrosion resistance, oxidation resistance, reactivity, etc.), thermal characteristic(s) (e.g., temperature, thermal conductivity, heat capacity, melting point, temperature stability, etc.), acoustic characteristic(s) (e.g., sound absorption, vibration damping, acoustic impedance, etc.), material characteristic(s) (e.g., hardness, density, elasticity, tensile strength, etc.), and environmental characteristic(s) (e.g., water resistance, UV resistance, etc.). In addition to performing measurements, the measurement device 110 may in some embodiments have other functionalities including, for example, analyzing the measured characteristic(s) and / or displaying and / or otherwise outputting that analysis for review by a user (e.g., an operator, technician, etc.) and / or an external device.

[0035] As seen in Fig. 3, the measurement device 110 may in some embodiments include a processing unit 116 coupled with (e.g., via wireless and / or wired communications) a sensing unit 118, a communication unit 120, a data storage unit 122, and / or a user interface 124. Additionally, in some embodiments, the measurement device 110 may include a platform or stage 126 for supporting the object for measurement. In some embodiments, the positioning device 112 may be configured to removably couple with the stage 126 including, for example, in a manner that when coupled at least a base or other portion of the positioning device 112 is fixedly or immovably secured to the stage 126.

[0036] In some embodiments, the sensing unit 118 may include one or more sensors configured to receive one or more signals from the drug container closure member 16 or other object being measured. In some embodiments, the sensing unit 118 may include one or more non-contact sensors configured to receive one or more optical, thermal, electrical, and / or magnetic signals emitted and / or reflected by the drug container closure member 16. Such non-contact sensors may include, for example, any one or combination of: laser displacement sensors, optical sensors, spectral sensors, confocal sensors, 2D and / or 3D laser scanners, vision sensors, ultrasonic sensors, inductive sensors, capacitive sensors, triangulation sensors, and the like. Additionally or alternatively, the sensing unit 118 may include one or more contact sensors configured to output a signal as a result of physical contact with the drug container closure member 16. Such contact sensors may include, for example, any one or combination of: contact displacement sensors, pressure sensors, strain gauges, proximity sensors, and the like.

[0037] In some embodiments, the processing unit 116 may be configured to analyze one or more signals output from and / or received by the sensing unit 118 to determine one or more characteristics of the drug container closure member 16. The processing unit 116 may perform these functions in real-time, or substantially in real-time, while, for example, the drug container closure member 16 is held by the positioning device 112 for measurement. In some embodiments, the processing unit 116 may take the form of a general purpose or special purpose computer, or any other suitable computing device. Furthermore, in some embodiments, the processing unit 116 may be a programmable logic controller, a desktop computer, a laptop computer, a tablet computer, a smartphone, a server, or some combination thereof. The processing unit 116 may be integrated into the measurement device 110 as shown in Fig. 3, or, in other embodiments, may be a standalone device, or may be distributed across multiple external devices. In some embodiments, the processing unit 116 may be an electrical device (e.g., a hard-wired circuit and / or circuit component), a combination of electrical devices, a mechanical device, a combination of mechanical devices, or a combination of mechanical and electrical devices. In some embodiments, the processing unit 116 may include one or more processors (e.g., microprocessors). Furthermore, in some embodiments, the processing unit 116 may not include a physical processor or other physical components and may be configured as a program module consisting of a set of non-transitory computer-readable instructions to be executed by a processor of a computer on which the program module is installed.

[0038] In some embodiments, the data storage unit 122 may include a non-transitory computer-readable storage medium configured to store data, including, for example, non-transitory computer-readable instructions constituting of one or more services or programs and any data operated on or produced by such services or programs. The data storage unit 122 may store10675-W001-SEC the data on a volatile (e.g., RAM) and / or non-volatile memory (e.g., a hard disk), and may be a removable or non-removable memory. The processing unit 116 may be configured to fetch and execute the instructions stored in the data storage unit 122 in order to perform various functions and methods described herein, including, for example, analyzing signal(s) from the sensing unit 118 to determine characteristic(s) of the drug container closure member 16.

[0039] In some embodiments, the user interface 124 may include any one or combination of at least: graphical display(s) (e.g., a liquid crystal display (LED) monitor, a touchscreen, etc.), input unit(s) (e.g., a keypad, a keyboard, buttons, knobs, etc.), light(s), and speaker(s). In some embodiments, executing the instructions stored in the data storage unit 122 may cause the processing unit 116 to control the user interface 124 to display visual representation (e.g., graphs, charts, tables, text, infographics, symbols, colored and / or flashing lights, etc.) and / or a sound indicative of, for example, the one or more characteristic(s) of the drug container closure member 16 determined by the processing unit 116. Additionally or alternatively, the user interface 124 may be configured to allow a user to set one or more measurement parameters and / or other parameters for the measurement device 110.

[0040] In some embodiments, the communication unit 120 may be configured to establish communication with external devices via a network (e.g., the Internet) and may include an antenna for wireless communications, a port for a wired connection, a connection to a modem, a connection to a router (e.g., a wireless router), or some combination thereof. In some embodiment embodiments, the communication unit 120 may be configured to transmit measurements taken by the measurement device 110 to an external device such as, for example, a remote computing device (e.g., a server or database operated by a manufacturer) and / or a local computing device (e.g., the user’s personal computer, smartphone, tablet, etc.).

[0041] The positioning device 112 may be configured to hold (e.g., support, secure, mount, arrange, align, and / or fix) the drug container closure member 16 in one or more positions (e.g., vertical position(s), horizontal position(s), rotational position(s), orientation(s), elevation(s), alignment(s), angle(s), inclination(s), displacement(s), distance(s) from a reference, etc.) allowing the measurement device 110 to measure one or more characteristics of the drug container closure member 16. In some embodiments, the positioning device 112 may function generally as a fixture. Furthermore, in some embodiments, the positioning device 112 may be configured to allow a user to automatically and / or manually adjust the position of the drug container closure member 16 with respect to the sensing unit 118 of the measurement device 110, for example, to ensure that the sensing unit 118 is properly aligned with the drug container closure member 16 to measure one or more chosen characteristics of the drug container closure member 16

[0042] In some embodiments, the positioning device 112 may include a base 128 and an arm 130 extending from the base 128. In some embodiments, the arm 130 may extend horizontally or substantially horizontally from the base 128, as depicted in Fig. 3. In certain such embodiments, a longitudinal axis A4 of the arm 130 may be horizontal or substantially horizontal. In alternative embodiments, the arm 130 may extend vertically or substantially vertically from the base 128, or in any other direction from the base 128. The arm 130 may be configured to hold the drug container closure member 16 at a distance from at least a portion of the base 128 such that, for example, the sensing unit 118 of the measurement device 110 has an unobstructed view of one or more, or all, sides of the drug container closure member 16. Furthermore, the arm 130 may be configured to hold the drug container closure member 16 in an elevated position above, for example, the support surface 114 and / or stage 126.

[0043] The arm 130 may include a first end 132 coupled with (e.g., removably coupled with) the base 128, a second end 134 coupled with (e.g., removably coupled with) the drug container closure member 16, and a middle portion 136 disposed between the first end 132 and the second end 134. In some embodiments, the second end 134 of the arm 130 may define a tip or terminal end of the arm 130. In some embodiments, the second end 134 of the arm 130 may be configured to couple with the drug container closure member 16 in a manner similar to or simulating the manner in which the drug container closure member 16 may couple with the plunger 14 when assembled to form the syringe 10. Furthermore, in some embodiments, the second end 134 of the arm 130 may be configured to couple with the drug container closure member 16 without causing deformation or10675-W001-SEC substantial deformation to the drug container closure member 16, thereby improving accuracy of measurement(s) taken by the measurement device 110.

[0044] The arm 130 may be made of a rigid material including, for example, metal (e.g., aluminum, stainless steel, etc.) and / or plastic and / or any other suitable material. In some embodiments, the arm 130 may be made of the same or a similar material as the plunger 14 which will couple with the drug container closure member 16 when they are assembled together in a drug delivery device such as syringe 10.

[0045] The arm 130 may have a generally cylindrical or other elongate or rod-like shape extending along the longitudinal axis A4. In some embodiments, the longitudinal axis A4 of the arm 130 may be parallel to and / or coaxial with the longitudinal axis A3 of the drug container closure member 16, for example, when the drug container closure member 16 is coupled with the second end 134 of the arm 130. In some embodiments, any one or combination of the first end 132, the second end 134, and the middle portion 136 of the arm 130 may be cylindrical or substantially cylindrical and / or have a cross-section, taken perpendicular to the longitudinal axis A4, which is circular or substantially circular.

[0046] In some embodiments, the first end 132 of the arm 130, or a portion thereof, may be configured for insertion into one or more openings 138a-c in the base 128. In certain such embodiments, the first end 132 of the arm 130 may have a threaded outer surface 140 configured to removably couple the arm 130 and the base 128, as seen in Figs. 5-7. The openings 138a-c may have, respectively, threaded inner surfaces 142a-c configured to threadably engage the threaded outer surface 140 of the arm 130. In addition to or as an alternative to the threaded surfaces, the first end 132 of the arm 130 and base 128 may removably couple with each other via a snap-fit connection, an interference-fit connection, a magnetic connection, and / or a connection involving one or more fasteners such as, for example, a screw. In some embodiments, the removable coupling between the arm 130 and the base 128 may allow various arms of different sizes and / or shapes to be interchangeably coupled with the base 128. These alternative arms can be configured to couple with different types of drug container closures and / or mimic or simulate different types of plungers for use in a drug delivery device such as a syringe. In some embodiments, these alternative arms may be included or packaged together, optionally along with the base 128 and / or other components, in a kit.

[0047] In some embodiments, the second end 134 of the arm 130, or a portion thereof, may be configured for insertion into the proximal axial opening 17 of the drug container closure member 16, for example, to retain or assist in retaining the drug container closure member 16 on the arm 130 before, during, and / or after a measurement by the measurement device 110. In certain such embodiments, the second end 134 of the arm 130 may include a longitudinally extending protrusion 144 sized for insertion into the proximal axial opening 17 of the drug container closure member 16 and / or configured to removably couple the arm 130 with the drug container closure member 16. In some embodiments, the longitudinally extending protrusion 144 may be parallel to and / or coaxial with the longitudinal axis A4 of the arm 130 and / or the longitudinal axis A3 of the drug container closure member 16 when the drug container closure member 16 is coupled with the arm 130. In some embodiments, the terminal end or tip of the longitudinally extending protrusion 144 may be conically shaped as seen in Figs. 6 and 7; whereas, in other embodiments, the terminal end or tip of the longitudinally extending protrusion 144 may be flat or planar, as seen in Figs. 8 and 9. In some embodiments, the longitudinally extending protrusion 144 may have generally cylindrical or other elongate or rod-like shape. In certain such embodiments, the longitudinally extending protrusion 144 may have a reduced diameter as compared to the middle portion 136 of the arm 130.

[0048] In some embodiments, the longitudinally extending protrusion 144 may be configured to form a snap-fit connection, an interference-fit, a magnetic connection, a threaded connection, and / or any other suitable connection with the drug container closure member 16. Furthermore, in some embodiments, the longitudinally extending protrusion 144 and / or another portion of the second end 134 of the arm 130 may be configured to couple with the drug container closure member 16 in a manner simulating and / or mimicking how the plunger 14 which will couple with the drug container closure member 16 when they are assembled together in a drug delivery deice such as the syringe 10. In alternative embodiments, the longitudinally extending10675-W001-SEC protrusion 144 may be omitted and the second end 134 of the arm 130 may removably couple with the drug container closure member 16 through other means including, for example, an adhesive, fastener, clamp, and / or screw.

[0049] Referring to Fig. 7, the first end 132 of the arm 130, the second end 134 of the arm 130, and the middle portion 136 of the arm 130 may have, respectively, a length LA1, a length LA2, and a length LA3. The lengths LA1-LA3 may each be parallel to the longitudinal axis A4 of the arm 130. In some embodiments, the length LA3 may be greater than the LA1, which may greater than the length LA2.

[0050] Furthermore, the first end 132 of the arm 130, the second end 134 of the arm 130, and the middle portion 136 of the arm 130 may have, respectively, a diameter DA1, a diameter DA2, and a diameter DA3. The diameters D1-D3 may each be perpendicular to the longitudinal axis A4 of the arm 130. In some embodiments, the diameter DA2 of the second end 134 of the arm 130 may correspond to a diameter of a portion, or the entirety, of the longitudinally extending protrusion 144. In some embodiments, the diameter DA2 of the second end 134 of the arm 130 may be less than the diameter D3 of the middle portion 136 of the arm 130.

[0051] In some embodiments, the diameter DA3 of the middle portion 136 of the arm 130 may be equal to or substantially equal to the diameter D of the drug container closure member 16 and / or a diameter of the plunger 14 which will couple with the drug container closure member 16 when they are assembled together in a drug delivery device such as the syringe 10. In alternative embodiments, the diameter DA3 of the middle portion 136 of the arm 130 may be greater than or less than the diameter D of the drug container closure member 16 and / or a diameter of the plunger 14 which will couple with the drug container closure member 16 when they are assembled together in a drug delivery device such as the syringe 10.

[0052] In some embodiments, the diameter DA3 of the middle portion 136 of the arm 130 may be equal to or substantially equal to the diameter D1 of the first end 132 of the arm 130, as seen in Figs. 5-7. In alternative embodiments, the diameter DA3 of the middle portion 136 of the arm 130 may be greater than the diameter D1 of the first end 132 of the arm 130.

[0053] The arm 130 may include any one or combination of the dimensions described below, or any other suitable dimension(s).

[0054] In some embodiments, the length LA1 of the first end 132 of the arm 130 may be less than or equal to approximately (e.g., ±10%) 20 mm, or less than or equal to approximately (e.g., ±10%) 18 mm, or within a range between approximately (e.g., ±10%) 10-20 mm, or within a range between approximately (e.g., ±10%) 13-18 mm. In some embodiments, the diameter DA1 of the first end 132 of the arm 130 may be less than or equal to approximately (e.g., ±10%) 10 mm, or less than or equal to approximately (e.g., ±10%) 7 mm, or within a range between approximately (e.g., ±10%) 4-8 mm, or within a range between approximately (e.g., ±10%) 5-7 mm.

[0055] In some embodiments, the length LA2 of the second end 134 of the arm 130 may be less than or equal to approximately (e.g., ±10%) 10 mm, or less than or equal to approximately (e.g., ±10%) 6 mm, or within a range between approximately (e.g., ±10%) 3-7 mm, or within a range between approximately (e.g., ±10%) 4-6 mm. In some embodiments, the diameter DA2 of the second end 134 of the arm 130 may be less than or equal to approximately (e.g., ±10%) 10 mm, or less than or equal to approximately (e.g., ±10%) 6 mm, or within a range between approximately (e.g., ±10%) 1-8 mm, or within a range between approximately (e.g., ±10%) 1.5-6 mm, or within a range between approximately (e.g., ±10%) 2-5.5 mm.

[0056] In some embodiments, the length LA3 of the middle portion 136 of the arm 130 may be less than or equal to approximately (e.g., ±10%) 75 mm, or less than or equal to approximately (e.g., ±10%) 60 mm, or within a range between approximately (e.g., ±10%) 50-60 mm, or within a range between approximately (e.g., ±10%) 53-58 mm. In some embodiments, the diameter DA3 of the middle portion 136 of the arm 130 may be less than or equal to approximately (e.g., ±10%) 20 mm, or less than or equal to approximately (e.g., ±10%) 15 mm, or within a range between approximately (e.g., ±10%) 5-15 mm, or within a range between approximately (e.g., ±10%) 8-13 mm.10675-W001-SEC

[0057] Referring to Figs. 3-5, the base 128 may include a stationary portion 146 and an adjustable portion 148. In some embodiments, the stationary portion 146 may be configured to removably couple with (e.g., via one or more fasteners) the measurement device 110, including, for example, the stage 126 and / or a frame of the measurement device 110. In other embodiments, the stationary portion 146 may not be coupled with the measurement device 110, instead merely resting upon the stage 126 and / or support surface 114 during measurements by the measurement device 110. In some embodiments, the adjustable portion 148 may be the portion of the base 128 which is configured to removable couple with the arm 130. As an example, one or more of the openings 138a-c may be formed in the adjustable portion 148 and may enable the arm 130 to be removably coupled with the adjustable portion 148 at various location(s).

[0058] In some embodiments, the adjustable portion 148 may be configured to rotate, translate vertically, translate horizontally, and / or move in another direction with respect to the stationary portion 146. The adjustable portion 148 may be rigidly yet removably coupled with the arm 130 such that movement of the adjustable portion 148 causes corresponding movement of the arm 130 when the arm 130 is coupled with the adjustable portion 148. This arrangement may allow a user (e.g., an operator, technician, etc.) to adjust the position of the drug container closure member 16 with respect to the sensing unit 118 of the measurement device 110 in order to, for example, enable the sensing unit 118 to measure different dimensions, positions, surface characteristics, and / or other characteristics of the drug container closure member 16. In some embodiments, the adjustable portion 148 may be temporarily fixed with respect to the stationary portion 146 once the drug container closure member 16 is arranged in a desired position. In other embodiments, the adjustable portion 148 may be permanently fixed with respect to the stationary portion 146 such that the adjustable portion 148 does not move with respect to the stationary portion 146 at any time. In some embodiments, the adjustable portion 148, or a portion thereof, may have a generally circular shape as seen in Figs. 4 and 5.

[0059] Movement of the adjustable portion 148 with respect to the stationary portion 146 may be achieved manually by a person and / or automatically by, for example, a motor. In some embodiments, the adjustable portion 148 may be configured to be manually rotated by a user with respect to the stationary portion 146. In certain such embodiments, the adjustable portion 148 may include a grip member 150 configured to facilitate a user gripping and / or rotating the adjustable portion 148 with his or her hand(s) and / or finger(s). In some embodiments, the grip member 150 may include a plurality of finger grooves arranged around a portion, or the entirety, of a perimeter or circumference of the adjustable portion 148.

[0060] In some embodiments, the stationary portion 146 may include a vertically extending support member or plate 152 configured to couple with the adjustable portion 148 and / or a horizontally extending support member or plate 154 configured to couple with, for example, the stage 126 of the measurement device 110. In some embodiments, the vertically extending support member 152 of the stationary portion 146 may be configured to rotatably couple with the adjustable portion 148 such that the adjustable portion 148 can rotate with respect to the vertically extending support member 152 of the stationary portion 146. In certain such embodiments, a rotational axis of the adjustable portion 148 may parallel to and / or coaxial with a longitudinal axis A4 of the arm 130 when the arm 130 is coupled with the adjustable portion 148.

[0061] Figs. 8 and 9 illustrate another embodiment of an arm, denoted with reference numeral 230, which is configured to couple with, for example, the base 128 of the positioning device 112. The arm 230 may be similar in many respects to the arm 130 described above in connection with Figs. 3-7. Features of the arm 230 which are not described in detail below may have similar or identical configurations, functions, and / or structure as the correspondingly numbered features described above in relation to the arm 130. Such features are assigned with the same reference numeral as used in Figs. 3-7, except incremented by 100.

[0062] The diameter DA3 of the middle portion 236 of the arm 230 is greater than a diameter DA1 of the first end 232 of the arm 230, the latter being equal to or substantially equal to the diameter DA1 of the first end 132 of the arm 130. With this configuration, the first end 232 of the arm 230 may be inserted into a similarly sized opening (e.g., one or openings 138a-c) in the10675-W001-SEC base 128 as the first end 132 of the arm 130. Accordingly, the arms 130 and 230 may utilize the same opening(s) for coupling to the base 128, albeit at different times depending on need or desire. Furthermore, the diameter DA3 of the middle portion 236 of the arm 230 may be larger than the diameter DA3 of the middle portion 136 of the arm 130, which may render the arm 230 suitable for holding a differently sized drug container closure member as compared to the arm 130. For example, the arm 230 may be suitable for holding a drug container closure member with a larger diameter than the one for which the arm 130 is designed or intended for. The larger diameter of the middle portion 236 of the arm 230 may, for example, improve the stability with which the arm 230 can support the drug container closure member with a larger diameter, reduce the likelihood of the arm 230 deforming the drug container closure member when the drug container closure member is coupled therewith, and / or more closely mimic a plunger which may be coupled with the drug container closure member when assembled within a drug delivery device.

[0063] In some embodiments, including the one illustrated in Figs. 8 and 9, the terminal end or tip of the longitudinally extending protrusion 244 of the second end 234 of the arm 230 may be flat or planar. This configuration may facilitate coupling with a drug container closure member having an internal cavity whose bottom is defined by a flat or planar inner surface. The terminal end or tip of the longitudinally extending protrusion 244, due to its flat or planar shape, may be flush or substantially flush with the flat or planar surface defining the internal cavity of the drug container closure member, thereby reducing the likelihood that longitudinally extending protrusion 244 may deform the drug container closure member when the drug container closure member is coupled therewith.

[0064] The foregoing systems and devices, and / or variants thereof, may be used in various methods for measuring a drug container closure member and / or other components. Any one or combination of the following steps may be performed manually by a user (e.g., an operator, technician, etc.) and / or automatically by a machine.

[0065] To begin, a user may set up or configure the positioning device 112 for holding the drug container closure member 16 so that it can be measured by the measurement device 110. The following setup steps may be performed in any sequence and are not limited to the specific sequence which is described. As an initial step, a user may select an appropriate arm (e.g., arm 130 or arm 230) for holding the drug container closure member during the measurement(s) depending on, for example, the type, size, weight, dimension(s), and / or other characteristic(s) of the drug container closure member 16. Next, the user may removably couple the drug container closure member 16 with the arm 130, assuming the arm 130 has been selected in the previous step. In some embodiments, this step may involve inserting the longitudinally extending protrusion 144 into the internal cavity 19 of the drug container closure member 16 until, for example, the middle portion 136 of the arm 130 contacts the drug container closure member 16. In other embodiments, the middle portion 136 of the arm 130 may not contact the drug container closure member 16, instead being spaced by an axial gap from the drug container closure member 16 when it is mounted on the longitudinally extending protrusion 144. Next, the user may removably couple the arm 130 with the base 128. In some embodiments, this step may involve screwing the threaded outer surface 140 of the first end 132 of the arm 130 into one of the openings 138a-c in the base 128. In alternative embodiments where, for example, the arm 130 is permanently coupled with the base 128, this step may be omitted. Next, the base 128, or more specifically the stationary portion 146 of the base 128, may be coupled with the stage 126 and / or a frame of the measurement device 110. In some embodiments, this step may involve aligning (e.g., vertically, horizontally, and / or rotationally aligning) the drug container closure member 16 with the sensing unit 118 of the measurement device 110. In alternative embodiments, the base 128 may not be coupled with the measurement device 110, instead merely be placed by the user to rest on the stage 126 and / or support surface 114, for example, with the drug container closure member 16 aligned with the sensing unit 118 of the measurement device 110. Next, optionally, the user may manually rotate the adjustable portion 148 of the base 128 to rotate the drug container closure member 16 into a first rotational position suitable for the sensing unit 118 of the measurement device 110 to measure particular dimension(s) and / or other characteristic(s) of the drug container closure member 16.10675-WC01-SEC

[0066] After the positioning device 112 and drug container closure member 16 have been set up or arranged, the user may operate the measurement device 110 to measure one or more characteristics of the drug container closure member 16. In some embodiments, the measurement device 110 may analyze one or more signals received from the sensing unit 118 to determine one or more characteristics of the drug container closure member 16 and then, optionally, display or otherwise output the determined characteristic(s) via the user interface 124 and / or transmit the determined characteristic(s) via the communication unit 120 to a remote computing device (e.g., a server or database operated by a manufacturer) and / or a local computing device (e.g., the user’s personal computer, smartphone, tablet, etc.).

[0067] In some embodiments, after a first measurement or set of measurements has been made, the positioning device 112 may be used to re-position the drug container closure member 16 to facilitate the measuring of one or more additional characteristics of the drug container closure member. This step may involve, for example, the user rotating the rotate the adjustable portion 148 of the base 128 to rotate the drug container closure member 16 from the first rotational position to a second rotational position.

[0068] Upon completing the desired measurement(s) of the drug container closure member 16, a user may remove the drug container closure member 16 from the arm 130 and, if it is a manufacturing setting, prepare and / or send the drug container closure member 16 for further processing, assembly, or other subsequent steps. If there are other drug container closure member(s) requiring measurement, the foregoing steps may be repeated, potentially with the arm 230 (instead of the arm 130) depending on the particularities of the drug container closure member(s) requiring measurement.

[0069] All features described herein, including in the specification, claims, abstract, and drawings, and all the steps in any method or process described herein, may be combined in any combination, except combinations where one or more of the features and / or steps are mutually exclusive.

[0070] As will be recognized, the systems and methods according to the present disclosure may have one or more advantages relative to conventional technology, any one or more of which may be present in a particular embodiment in accordance with the features of the present disclosure included in that embodiment. Other advantages not specifically listed herein may also be recognized as well.

[0071] The above description describes various devices, assemblies, components, subsystems and methods for use related to a drug delivery device. The devices, assemblies, components, subsystems, methods or drug delivery devices can further comprise or be used with a drug including but not limited to those drugs identified below as well as their generic and biosimilar counterparts. The term drug, as used herein, can be used interchangeably with other similar terms and can be used to refer to any type of medicament or therapeutic material including traditional and non-traditional pharmaceuticals, nutraceuticals, supplements, biologies, biologically active agents and compositions, large molecules, biosimilars, bioequivalents, therapeutic antibodies, polypeptides, proteins, small molecules and generics. Non-therapeutic injectable materials are also encompassed. The drug may be in liquid form, a lyophilized form, or in a reconstituted from lyophilized form. The following example list of drugs should not be considered as all-inclusive or limiting.

[0072] The drug will be contained in a reservoir. In some instances, the reservoir is a primary container that is either filled or pre-filled for treatment with the drug. The primary container can be a vial, a cartridge or a pre-filled syringe.

[0073] In some embodiments, the reservoir of the drug delivery device may be filled with or the device can be used with colony stimulating factors, such as granulocyte colony-stimulating factor (G-CSF). Such G-CSF agents include but are not limited to Neulasta® (pegfilgrastim, pegylated filgastrim, pegylated G-CSF, pegylated hu-Met-G-CSF) and Neupogen® (filgrastim, G-CSF, hu-MetG-CSF), UDENYCA® (pegfilgrastim-cbqv), Ziextenzo® (LA-EP2006; pegfilgrastim-bmez), or FULPHILA (pegfilgrastim- bmez).

[0074] In other embodiments, the drug delivery device may contain or be used with an erythropoiesis stimulating agent (ESA), which may be in liquid or lyophilized form. An ESA is any molecule that stimulates erythropoiesis. In some embodiments, an ESA10675-W001-SEC is an erythropoiesis stimulating protein. As used herein, “erythropoiesis stimulating protein” means any protein that directly or indirectly causes activation of the erythropoietin receptor, for example, by binding to and causing dimerization of the receptor. Erythropoiesis stimulating proteins include erythropoietin and variants, analogs, or derivatives thereof that bind to and activate erythropoietin receptor; antibodies that bind to erythropoietin receptor and activate the receptor; or peptides that bind to and activate erythropoietin receptor. Erythropoiesis stimulating proteins include, but are not limited to, Epogen® (epoetin alfa), Aranesp® (darbepoetin alfa), Dynepo® (epoetin delta), Mircera® (methyoxy polyethylene glycol-epoetin beta), Hematide®, MRK- 2578, INS-22, Retacrit® (epoetin zeta), Neorecormon® (epoetin beta), Silapo® (epoetin zeta), Binocrit® (epoetin alfa), epoetin alfa Hexal, Abseamed® (epoetin alfa), Ratioepo® (epoetin theta), Eporatio® (epoetin theta), Biopoin® (epoetin theta), epoetin alfa, epoetin beta, epoetin iota, epoetin omega, epoetin delta, epoetin zeta, epoetin theta, and epoetin delta, pegylated erythropoietin, carbamylated erythropoietin, as well as the molecules or variants or analogs thereof.

[0075] Among particular illustrative proteins are the specific proteins set forth below, including fusions, fragments, analogs, variants or derivatives thereof: OPGL specific antibodies, peptibodies, related proteins, and the like (also referred to as RANKL specific antibodies, peptibodies and the like), including fully humanized and human OPGL specific antibodies, particularly fully humanized monoclonal antibodies; Myostatin binding proteins, peptibodies, related proteins, and the like, including myostatin specific peptibodies; IL-4 receptor specific antibodies, peptibodies, related proteins, and the like, particularly those that inhibit activities mediated by binding of IL-4 and / or IL-13 to the receptor; Interleukin 1-receptor 1 (“IL1-R1”) specific antibodies, peptibodies, related proteins, and the like; Ang2 specific antibodies, peptibodies, related proteins, and the like; NGF specific antibodies, peptibodies, related proteins, and the like; CD22 specific antibodies, peptibodies, related proteins, and the like, particularly human CD22 specific antibodies, such as but not limited to humanized and fully human antibodies, including but not limited to humanized and fully human monoclonal antibodies, particularly including but not limited to human CD22 specific IgG antibodies, such as, a dimer of a human-mouse monoclonal h LL2 gamma-chain disulfide linked to a human-mouse monoclonal h LL2 kappa-chain, for example, the human CD22 specific fully humanized antibody in Epratuzumab, CAS registry number 501423-23-0; IGF-1 receptor specific antibodies, peptibodies, and related proteins, and the like including but not limited to anti- IGF-1 R antibodies; B-7 related protein 1 specific antibodies, peptibodies, related proteins and the like (“B7RP-1” and also referring to B7H2, ICOSL, B7h, and CD275), including but not limited to B7RP-specific fully human monoclonal I gG2 antibodies, including but not limited to fully human I gG2 monoclonal antibody that binds an epitope in the first immunoglobulin-like domain of B7RP-1, including but not limited to those that inhibit the interaction of B7RP-1 with its natural receptor, ICOS, on activated T cells; IL-15 specific antibodies, peptibodies, related proteins, and the like, such as, in particular, humanized monoclonal antibodies, including but not limited to HuMax IL-15 antibodies and related proteins, such as, for instance, 145c7; IFN gamma specific antibodies, peptibodies, related proteins and the like, including but not limited to human IFN gamma specific antibodies, and including but not limited to fully human anti-IFN gamma antibodies; TALL-1 specific antibodies, peptibodies, related proteins, and the like, and other TALL specific binding proteins; Parathyroid hormone (“PTH”) specific antibodies, peptibodies, related proteins, and the like; Thrombopoietin receptor (“TPO-R”) specific antibodies, peptibodies, related proteins, and the like; Hepatocyte growth factor (“HGF”) specific antibodies, peptibodies, related proteins, and the like, including those that target the HGF / SF:cMet axis (HGF / SF:c-Met), such as fully human monoclonal antibodies that neutralize hepatocyte growth factor / scatter (HGF / SF); TRAIL-R2 specific antibodies, peptibodies, related proteins and the like; Activin A specific antibodies, peptibodies, proteins, and the like; TGF-beta specific antibodies, peptibodies, related proteins, and the like; Amyloid-beta protein specific antibodies, peptibodies, related proteins, and the like; c-Kit specific antibodies, peptibodies, related proteins, and the like, including but not limited to proteins that bind c-Kit and / or other stem cell factor receptors; OX40L specific antibodies, peptibodies, related proteins, and the like, including but not limited to proteins that bind OX40L and / or other ligands of the 0X40 receptor; Activase® (alteplase, tPA); Aranesp® (darbepoetin alfa) Erythropoietin [30-asparagine, 32-threonine, 87-valine, 88-asparagine, 90-threonine], Darbepoetin alfa, novel erythropoiesis stimulating protein (NESP); Epogen® (epoetin alfa, or erythropoietin); GLP-10675-W001-SEC1, Avonex® (interferon beta-1 a); Bexxar® (tositumomab, anti-CD22 monoclonal antibody); Betaseron® (interferon-beta); Campath® (alemtuzumab, anti-CD52 monoclonal antibody); Dynepo® (epoetin delta); Velcade® (bortezomib); MLN0002 (anti- a4B7 mAb); MLN1202 (anti-CCR2 chemokine receptor mAb); Enbrel® (etanercept, TNF-receptor / Fc fusion protein, TNF blocker); Eprex® (epoetin alfa); Erbitux® (cetuximab, anti-EGFR / HER1 / c-ErbB-1); Genotropin® (somatropin, Human Growth Hormone); Herceptin® (trastuzumab, anti-HER2 / neu (erbB2) receptor mAb); Kanjinti ™ (trastuzumab-anns) anti-HER2 monoclonal antibody, biosimilar to Herceptin®, or another product containing trastuzumab for the treatment of breast or gastric cancers; Humatrope® (somatropin, Human Growth Hormone); Humira® (adalimumab); Vectibix® (panitumumab), Xgeva® (denosumab), Prolia® (denosumab), Immunoglobulin G2 Human Monoclonal Antibody to RANK Ligand, Enbrel® (etanercept, TNF-receptor / Fc fusion protein, TNF blocker), Nplate® (romiplostim), rilotumumab, ganitumab, conatumumab, brodalumab, insulin in solution; Infergen® (interferon alfacon-1); Natrecor® (nesiritide; recombinant human B-type natriuretic peptide (hBNP); Kineret® (anakinra); Leukine® (sargamostim, rhuGM-CSF); LymphoCide® (epratuzumab, anti-CD22 mAb); Benlysta™ (lymphostat B, belimumab, anti-BlyS mAb); Metalyse® (tenecteplase, t-PA analog); Mircera® (methoxy polyethylene glycol- epoetin beta); Mylotarg® (gemtuzumab ozogamicin); Raptiva® (efalizumab); Cimzia® (certolizumab pegol, CDP 870); Soliris™ (eculizumab); pexelizumab (anti-C5 complement); Numax® (MEDI-524); Lucentis® (ranibizumab); Panorex® (17-1 A, edrecolomab); Trabio® (lerdelimumab); TheraCim hR3 (nimotuzumab); Omnitarg (pertuzumab, 2C4); Osidem® (IDM-1); OvaRex® (B43.13); Nuvion® (visilizumab); cantuzumab mertansine (huC242-DM1); NeoRecormon® (epoetin beta); Neumega® (oprelvekin, human interleukin-11); Orthoclone OKT3® (muromonab-CD3, anti-CD3 monoclonal antibody); Procrit® (epoetin alfa); Remicade® (infliximab, anti-TNFa monoclonal antibody); Reopro® (abciximab, anti-GP llb / llia receptor monoclonal antibody); Actemra® (anti-l L6 Receptor mAb); Avastin® (bevacizumab), HuMax-CD4 (zanolimumab); MvasiTM (bevacizumab- awwb); Rituxan® (rituximab, anti-CD20 mAb); Tarceva® (erlotinib); Roferon-A®-(interferon alfa-2a); Simulect® (basiliximab); Prexige® (lumiracoxib); Synagis® (palivizumab); 145c7-CHO (anti-IL15 antibody, see U.S. Patent No. 7,153,507); Tysabri® (natalizumab, anti-a4integrin mAb); Valortim® (MDX-1303, anti-B. anthracis protective antigen mAb); ABthrax™; Xolair® (omalizumab); ETI211 (anti-MRSA mAb); IL-1 trap (the Fc portion of human I gG 1 and the extracellular domains of both IL-1 receptor components (the Type I receptor and receptor accessory protein)); VEGF trap (Ig domains of VEGFR1 fused to I gG 1 Fc); Zenapax® (daclizumab); Zenapax® (daclizumab, anti-l L-2Ra mAb); Zevalin® (ibritumomab tiuxetan); Zetia® (ezetimibe); Orencia® (atacicept, TACI-lg); anti-CD80 monoclonal antibody (galiximab); anti-CD23 mAb (lumiliximab); BR2-Fc (huBR3 / huFc fusion protein, soluble BAFF antagonist); ONTO 148 (golimumab, anti-TNFa mAb); HGS-ETR1 (mapatumumab; human anti- TRAIL Receptor-1 mAb); HuMax-CD20 (ocrelizumab, anti-CD20 human mAb); HuMax-EGFR (zalutumumab); M200 (volociximab, anti-a5 1 integrin mAb); MDX-010 (ipilimumab, anti-CTLA-4 mAb and VEGFR-1 (IMC-18F1); anti-BR3 mAb; anti- C. difficile Toxin A and Toxin B C mAbs MDX-066 (CDA-1) and MDX-1388); anti-CD22 dsFv-PE38 conjugates (CAT-3888 and CAT-8015); anti-CD25 mAb (HuMax-TAC); anti-CD3 mAb (NI-0401); adecatumumab; anti-CD30 mAb (MDX-060); MDX-1333 (anti-IFNAR); anti-CD38 mAb (HuMax CD38); anti-CD40L mAb; anti-Cripto mAb; anti-CTGF Idiopathic Pulmonary Fibrosis Phase I Fibrogen (FG-3019); anti-CTLA4 mAb; anti-eotaxin1 mAb (CAT-213); anti-FGF8 mAb; anti-ganglioside GD2 mAb; antiganglioside GM2 mAb; anti-GDF-8 human mAb (MYO-029); anti-GM-CSF Receptor mAb (CAM-3001); anti-HepC mAb (HuMax HepC); anti-l FNa mAb (MEDI-545, MDX-198); anti-IGF1 R mAb; anti-IGF-1 R mAb (HuMax-Inflam); anti-IL12 mAb (ABT-874); anti-IL12 / IL23 mAb (CNTO 1275); anti-l L13 mAb (CAT-354); anti-IL2Ra mAb (HuMax-TAC); anti-IL5 Receptor mAb; anti-integrin receptors mAb (MDX-018, CNTO 95); anti-IP10 Ulcerative Colitis mAb (MDX-1100); BMS-66513; anti-Mannose Receptor / hCGp mAb (MDX-1307); anti-mesothelin dsFv-PE38 conjugate (CAT-5001); anti-PD1mAb (MDX-1106 (ONO-4538)); anti-PDGFRa antibody (IMC-3G3); anti-TGFB mAb (GC-1008); anti-TRAIL Receptor-2 human mAb (HGS-ETR2); anti-TWEAK mAb; anti- VEGFR / Flt-1 mAb; and anti-ZP3 mAb (HuMax-ZP3).

[0076] In some embodiments, the drug delivery device may contain or be used with a sclerostin antibody, such as but not limited to romosozumab, blosozumab, BPS 804 (Novartis), Evenity™ (romosozumab-aqqg), another product containing10675-W001-SEC romosozumab for treatment of postmenopausal osteoporosis and / or fracture healing and in other embodiments, a monoclonal antibody (IgG) that binds human Proprotein Convertase Subtilisin / Kexin Type 9 (PCSK9). Such PCSK9 specific antibodies include, but are not limited to, Repatha® (evolocumab) and Praluent® (alirocumab). In other embodiments, the drug delivery device may contain or be used with rilotumumab, bixalomer, trebananib, ganitumab, conatumumab, motesanib diphosphate, brodalumab, vidupiprant or panitumumab. In some embodiments, the reservoir of the drug delivery device may be filled with or the device can be used with IMLYGIC® (talimogene laherparepvec) or another oncolytic HSV for the treatment of melanoma or other cancers including but are not limited to OncoVEXGALV / CD; OrienXOW; G207, 1716; NV1020; NV12023; NV1034; and NV1042. In some embodiments, the drug delivery device may contain or be used with endogenous tissue inhibitors of metalloproteinases (TIMPs) such as but not limited to TIMP-3. In some embodiments, the drug delivery device may contain or be used with Aimovig® (erenumab-aooe), anti-human CGRP-R (calcitonin gene-related peptide type 1 receptor) or another product containing erenumab for the treatment of migraine headaches. Antagonistic antibodies for human calcitonin gene-related peptide (CGRP) receptor such as but not limited to erenumab and bispecific antibody molecules that target the CGRP receptor and other headache targets may also be delivered with a drug delivery device of the present disclosure. Additionally, bispecific T cell engager (BiTE®) molecules such as but not limited to BLINCYTO® (blinatumomab) can be used in or with the drug delivery device of the present disclosure. In some embodiments, the drug delivery device may contain or be used with an APJ large molecule agonist such as but not limited to apelin or analogues thereof. In some embodiments, a therapeutically effective amount of an anti-thymic stromal lymphopoietin (TSLP) or TSLP receptor antibody is used in or with the drug delivery device of the present disclosure. In some embodiments, the drug delivery device may contain or be used with AvsolaTM (infliximab-axxq), anti- TNF a monoclonal antibody, biosimilar to Remicade® (infliximab) (Janssen Biotech, Inc.) or another product containing infliximab for the treatment of autoimmune diseases. In some embodiments, the drug delivery device may contain or be used with Kyprolis® (carfilzomib), (2S)-N-((S)-1-((S)-4-methyl-1-((R)-2-methyloxiran-2-yl)-1 -oxopentan-2-ylcarbamoyl)-2-phenylethyl)-2- ((S)-2-(2-morpholinoacetamido)-4-phenylbutanamido)-4-methylpentanamide, or another product containing carfilzomib for the treatment of multiple myeloma. In some embodiments, the drug delivery device may contain or be used with Otezla® (apremilast), N-[2-[(1 S)-1-(3-ethoxy-4-methoxyphenyl)-2-(methylsulfonyl)ethyl]-2,3-dihydro-1 ,3-dioxo- 1 H-isoindol-4-yl]acetamide, or another product containing apremilast for the treatment of various inflammatory diseases. In some embodiments, the drug delivery device may contain or be used with ParsabivTM (etelcalcetide HCI, KAI-4169) or another product containing etelcalcetide HCI for the treatment of secondary hyperparathyroidism (sHPT) such as in patients with chronic kidney disease (KD) on hemodialysis. In some embodiments, the drug delivery device may contain or be used with ABP 798 (rituximab), a biosimilar candidate to Rituxan® / MabThera™, or another product containing an anti-CD20 monoclonal antibody. In some embodiments, the drug delivery device may contain or be used with a VEGF antagonist such as a non-antibody VEGF antagonist and / or a VEGF-Trap such as aflibercept (Ig domain 2 from VEGFR1 and Ig domain 3 from VEGFR2, fused to Fc domain of I gG 1 ) . In some embodiments, the drug delivery device may contain or be used with ABP 959 (eculizumab), a biosimilar candidate to Soliris®, or another product containing a monoclonal antibody that specifically binds to the complement protein C5. In some embodiments, the drug delivery device may contain or be used with Rozibafusp alfa (formerly AMG 570) is a novel bispecific antibody-peptide conjugate that simultaneously blocks ICOSL and BAFF activity. In some embodiments, the drug delivery device may contain or be used with Omecamtiv mecarbil, a small molecule selective cardiac myosin activator, or myotrope, which directly targets the contractile mechanisms of the heart, or another product containing a small molecule selective cardiac myosin activator. In some embodiments, the drug delivery device may contain or be used with Sotorasib (formerly known as AMG 510), a KRASG12C small molecule inhibitor, or another product containing a KRASG12C small molecule inhibitor. In some embodiments, the drug delivery device may contain or be used with Tezepelumab, a human monoclonal antibody that inhibits the action of thymic stromal lymphopoietin (TSLP), or another product containing a human monoclonal antibody that inhibits the action of TSLP. In some embodiments, the drug delivery device may contain or be used10675-W001-SEC with AMG 714, a human monoclonal antibody that binds to Interleukin-15 (IL-15) or another product containing a human monoclonal antibody that binds to Interleukin-15 (IL-15). In some embodiments, the drug delivery device may contain or be used with AMG 890, a small interfering RNA (siRNA) that lowers lipoprotein(a), also known as Lp(a), or another product containing a small interfering RNA (siRNA) that lowers lipoprotein(a). In some embodiments, the drug delivery device may contain or be used with ABP 654 (human IgG 1 kappa antibody), a biosimilar candidate to Stelara®, or another product that contains human IgG 1 kappa antibody and / or binds to the p40 subunit of human cytokines interleukin (I L)-12 and IL-23. In some embodiments, the drug delivery device may contain or be used with AmjevitaTM or AmgevitaTM (formerly ABP 501) (mab anti-TNF human lgG1), a biosimilar candidate to Humira®, or another product that contains human mab anti-TNF human lgG1. In some embodiments, the drug delivery device may contain or be used with AMG 160, or another product that contains a half-life extended (HLE) anti- prostate-specific membrane antigen (PSMA) x anti-CD3 BiTE® (bispecific T cell engager) construct. In some embodiments, the drug delivery device may contain or be used with AMG 119, or another product containing a delta-like ligand 3 (DLL3) CAR T (chimeric antigen receptor T cell) cellular therapy. In some embodiments, the drug delivery device may contain or be used with AMG 119, or another product containing a delta-like ligand 3 (DLL3) CAR T (chimeric antigen receptor T cell) cellular therapy. In some embodiments, the drug delivery device may contain or be used with AMG 133, or another product containing a gastric inhibitory polypeptide receptor (GIPR) antagonist and GLP-1 R agonist. In some embodiments, the drug delivery device may contain or be used with AMG 171 or another product containing a Growth Differential Factor 15 (GDF15) analog. In some embodiments, the drug delivery device may contain or be used with AMG 176 or another product containing a small molecule inhibitor of myeloid cell leukemia 1 (MCL-1). In some embodiments, the drug delivery device may contain or be used with AMG 199 or another product containing a half-life extended (HLE) bispecific T cell engager construct (BiTE®). In some embodiments, the drug delivery device may contain or be used with AMG 256 or another product containing an anti-PD-1 x IL21 mutein and / or an IL-21 receptor agonist designed to selectively turn on the Interleukin 21 (IL-21) pathway in programmed cell death-1 (PD-1) positive cells. In some embodiments, the drug delivery device may contain or be used with AMG 330 or another product containing an anti-CD33 x anti-CD3 BiTE® (bispecific T cell engager) construct. In some embodiments, the drug delivery device may contain or be used with AMG 404 or another product containing a human anti-programmed cell death-1 (PD-1) monoclonal antibody being investigated as a treatment for patients with solid tumors. In some embodiments, the drug delivery device may contain or be used with AMG 427 or another product containing a half-life extended (HLE) anti-fms-like tyrosine kinase 3 (FLT3) x anti-CD3 BiTE® (bispecific T cell engager) construct. In some embodiments, the drug delivery device may contain or be used with AMG 430 or another product containing an anti-Jagged-1 monoclonal antibody. In some embodiments, the drug delivery device may contain or be used with AMG 506 or another product containing a multi-specific FAP x 4-1 BB-targeting DARPin® biologic under investigation as a treatment for solid tumors. In some embodiments, the drug delivery device may contain or be used with AMG 509 or another product containing a bivalent T-cell engager and is designed using XmAb® 2+1 technology. In some embodiments, the drug delivery device may contain or be used with AMG 562 or another product containing a half-life extended (HLE) CD19 x CD3 BiTE® (bispecific T cell engager) construct. In some embodiments, the drug delivery device may contain or be used with Efavaleukin alfa (formerly AMG 592) or another product containing an IL-2 mutein Fc fusion protein. In some embodiments, the drug delivery device may contain or be used with AMG 596 or another product containing a CD3 x epidermal growth factor receptor vl 11 (EGFRvlll) BiTE® (bispecific T cell engager) molecule. In some embodiments, the drug delivery device may contain or be used with AMG 673 or another product containing a half-life extended (HLE) anti-CD33 x anti- CD3 BiTE® (bispecific T cell engager) construct. In some embodiments, the drug delivery device may contain or be used with AMG 701 or another product containing a half-life extended (HLE) anti-B-cell maturation antigen (BCMA) x anti-CD3 BiTE® (bispecific T cell engager) construct. In some embodiments, the drug delivery device may contain or be used with AMG 757 or another product containing a half-life extended (HLE) anti- delta-like ligand 3 (DLL3) x anti-CD3 BiTE® (bispecific T cell engager)10675-W001-SEC construct. In some embodiments, the drug delivery device may contain or be used with AMG 910 or another product containing a half-life extended (HLE) epithelial cell tight junction protein claudin 18.2 x CD3 BiTE® (bispecific T cell engager) construct.

[0077] Although the drug delivery devices, assemblies, components, subsystems and methods have been described in terms of exemplary embodiments, they are not limited thereto. The detailed description is to be construed as exemplary only and does not describe every possible embodiment of the present disclosure. Numerous alternative embodiments could be implemented, using either current technology or technology developed after the filing date of this patent that would still fall within the scope of the claims defining the invention(s) disclosed herein.

[0078] Those skilled in the art will recognize that a wide variety of modifications, alterations, and combinations can be made with respect to the above described embodiments without departing from the spirit and scope of the invention(s) disclosed herein, and that such modifications, alterations, and combinations are to be viewed as being within the ambit of the inventive concept(s).

Claims

10675-W001-SECWhat is claimed is:

1. A system for measuring a drug container closure member, the system comprising: a measurement device configured to measure at least one characteristic of the drug container closure member; and a positioning device comprising: a base, and an arm configured to extend from the base and hold the drug container closure member in at least one position allowing the measurement device to measure the at least one characteristic of the drug container closure member.

2. The system of claim 1, wherein the at least one characteristic comprises at least one of: a dimension of the drug container closure member, a position of the drug container closure member, and a surface characteristic of the drug container closure member.

3. The system of any one of claims 1 or 2, wherein at least a portion of the arm is configured to extend in a horizontal or substantially horizontal direction when the arm is coupled with the base.

4. The system of any one of claims 1 to 3, wherein the arm comprises a first end configured to removably couple with the base, a second end configured to removably couple with the drug container closure member, and a middle portion disposed between the first end and the second end.

5. The system of claim 4, wherein the second end of the arm comprises a longitudinally extending protrusion configured to be inserted into an opening in the drug container closure member.

6. The system of claim 5, wherein a diameter of the longitudinally extending protrusion is less than a diameter of the middle portion of the arm disposed.

7. The system of any one of claims 4 to 6, wherein the first end of the arm comprises a threaded outer surface.

8. The system of any one of claims 4 to 7, wherein at least the middle portion of the arm is cylindrical or substantially cylindrical.

9. The system of claim 8, wherein a diameter of the middle portion of the arm is equal to or substantially equal to a diameter of the drug container closure member.

10. The system of any one of claims 8 or 9, wherein a diameter of the middle portion of the arm is less than or equal to 15 mm.

11. The system of any one of claims 1 to 10, wherein a longitudinal axis of the arm is parallel to and / or coaxial with a longitudinal axis of the drug container closure member when the drug container closure member is removably coupled with the arm.10675-W001-SEC12. The system of any one of claims 1 to 11, wherein the base comprises a stationary portion and an adjustable portion, wherein the adjustable portion is configured to rotate relative to the stationary portion.

13. The system of claim 12, wherein the arm is removably coupled with the adjustable portion.

14. The system of any one of claims 12 or 13, wherein the adjustable portion is configured to be manually rotated by a user.

15. The system of any one of claims 1 to 14, wherein the positioning device is not coupled with the measurement device.

16. The system of any one of claims 1 to 15, wherein the measurement device is configured to measure the at least one characteristic of the drug container closure member without contacting the drug container closure member.

17. The system of any one of claims 1 to 16, wherein the measurement device comprises: a sensor configured to receive at least one signal from the drug container closure member; a processing unit coupled with the sensor and configured to analyze the at least one signal to determine the at least one characteristic of the drug container closure member; and a user interface for setting measurement parameters and / or displaying measurement results.

18. A method comprising: providing a measurement device configured to measure at least one characteristic of a drug container closure member; providing a positioning device comprising a base and a first arm configured to extend from the base; removably coupling a drug container closure member to a first arm; and positioning the first arm to allow the measurement device to measure the at least one characteristic of the drug container closure member.

19. The method of claim 18, comprising operating the measurement device to measure the at least one characteristic of the drug container closure member.

20. The method of any one of claims 18 or 19, comprising removably coupling the first arm to the base of the positioning device.

21. The method of claim 20, comprising removably coupling the drug container closure member to the first arm prior to removably coupling the first arm with the base of the positioning device.

22. The method of any one of claims 20 or 21, wherein at least a portion of the first arm extends in a horizontal or substantially horizontal direction when the first arm is removably coupled with the base of the positioning device.

23. The method of any one of claims 18 to 22, comprising decoupling the first arm from the base of the positioning device and removably coupling a second arm with the base of the positioning device.10675-W001-SEC24. The method of claim 23, comprising removably coupling a second drug container closure member with the second arm and positioning the second arm to allow the measurement device to measure at least one characteristic of the second drug container closure member.

25. The method of any one of claims 18 to 24, wherein the at least one characteristic comprises at least one of: a dimension of the drug container closure member, a position of the drug container closure member, and a surface characteristic of the drug container closure member.

26. The method of any one of claims 18 to 25, wherein the first arm comprises a first end configured to removably couple with the base, a second end configured to removably couple with the drug container closure member, and a middle portion disposed between the first end and the second end.

27. The method of claim 26, wherein the second end of the first arm comprises a longitudinally extending protrusion configured to be inserted into an opening in the drug container closure member.

28. The method of claim 27, wherein a diameter of the longitudinally extending protrusion is less than a diameter of the middle portion of the first arm.

29. The method of any one of claims 26 to 28, wherein the first end of the first arm comprises a threaded outer surface.

30. The method of any one of claims 26 to 29, wherein a diameter of the middle portion of the first arm is equal to or substantially equal to a diameter of the drug container closure member.

31. The method of any one of claims 18 to 30, comprising removably coupling the positioning device with the measurement device.

32. The method of any one of claims 18 to 31, wherein a longitudinal axis of the first arm is parallel to and / or coaxial with a longitudinal axis of the drug container closure member when the drug container closure member is removably coupled with the first arm.

33. The method of any one of claims 18 to 32, wherein the base comprises a stationary portion and an adjustable portion, wherein the adjustable portion is configured to rotate relative to the stationary portion, and wherein the first arm is removably coupled with the adjustable portion.

34. The method of claim 33, comprising: rotating the adjustable portion of the base to rotate the drug container closure member from a first rotational position to a second rotational position; and operating the measurement device to measure at least a second characteristic of the drug container closure member when the drug container closure member is in the second rotational position.10675-W001-SEC35. The method of claim 34, wherein a user manually rotates the adjustable portion of the base to rotate the drug container closure member from the first rotational position to the second rotational position.

36. The method of any one of claims 18 to 35, wherein the measurement device comprises: a sensor configured to receive at least one signal from the drug container closure member; a processing unit coupled with the sensor and configured to analyze the at least one signal to determine the at least one characteristic of the drug container closure member; and a user interface for setting measurement parameters and / or displaying measurement results.

37. A positioning device for use in measuring a drug container closure member, the positioning device comprising: a base; and an arm configured to extend from the base and hold the drug container closure member in at least one position allowing measurement of at least one characteristic of the drug container closure member.

38. The positioning device of claim 37, wherein at least a portion of the arm is configured to extend in a horizontal or substantially horizontal direction when the arm is coupled with the base.

39. The positioning device of any one of claims 37 or 38, wherein the arm comprises a first end configured to removably couple with the base, a second end configured to removably couple with the drug container closure member, and a middle portion disposed between the first end and the second end.

40. The positioning device of claim 39, wherein the second end of the arm comprises a longitudinally extending protrusion configured to be inserted into an opening in the drug container closure member.

41. The positioning device of claim 40, wherein a diameter of the longitudinally extending protrusion is less than a diameter of the middle portion of the arm.

42. The positioning device of any one of claims 39 to 41, wherein the first end of the arm comprises a threaded outer surface.

43. The positioning device of any one of claims 39 to 42, wherein at least the middle portion of the arm is cylindrical or substantially cylindrical.

44. The positioning device of claim 43, wherein a diameter of the middle portion of the arm is equal to or substantially equal to a diameter of the drug container closure member.

45. The positioning device of any one of claims 43 or 44, wherein a diameter of the middle portion of the arm is less than or equal to 15 mm.

46. The positioning device of any one of claims 37 to 45, wherein a longitudinal axis of the arm is parallel to and / or coaxial with a longitudinal axis of the drug container closure member when the drug container closure member is removably coupled with the arm.10675-W001-SEC47. The positioning device of any one of claims 37 to 46, wherein the base comprises a stationary portion and an adjustable portion, wherein the adjustable portion is configured to rotate relative to the stationary portion.

48. The positioning device of claim 47, wherein the arm is removably coupled with the adjustable portion.

49. The positioning device of any one of claims 47 or 48, wherein the adjustable portion is configured to be manually rotated by a user.

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