Systems for use during external sterilization of drug delivery devices

Abstract

Various systems for use during an external sterilization process of a plurality of drug delivery devices are provided. The system comprises a tray including at least one partition at least partially enclosed by the tray, and a rack including a metal frame and a plurality of rails fixed to the metal frame. The plurality of rails are configured to support the tray within the rack. The partition may define a plurality of chambers, and each of the plurality of chambers may be configured to receive a plurality of drug delivery devices in a front-to-back configuration.

Description

11105-W001-SECSYSTEMS FOR USE DURING EXTERNAL STERILIZATION OF DRUG DELIVERY DEVICES CROSS-REFERENCE TO RELATED APPLICATIONS

[0001] The present application claims priority to U.S. Provisional Patent Application No. 63 / 760,238, filed February 19, 2025.TECHNICAL FIELD

[0002] This disclosure generally relates to drug delivery devices. More particularly, the disclosure generally relates to systems for use during external sterilization of drug delivery devices.BACKGROUND

[0003] Drug delivery devices, such as syringes, are used to administer a medicament to a patient. Such drug delivery devices are often marketed either in pre-filled form (also referred to as “combination products”), wherein a set dosage or amount of medicament may be provided therein, or they are empty and intended to be filled from a vial or other source of medicament by an end user at the time administration of the medicament is desired. Syringes, for example, often include a barrel portion adapted to retain the medicament, a conventional piercing element such as a needle, a plunger rod, an elastomeric or rubber-like stopper element fitted in a substantially fluid-tight manner within the interior of the barrel, and a flange around the open proximal end of the syringe barrel as a form of finger rest to facilitate a user's manipulation of the device. It may be desirable, both for integrity of the medicament as well as for patient safety, to sufficiently sterilize the components of the combination products. For pre-filled syringe combination products, for example, sterilization may occur at several stages in the assembly process, including pre-fill stages (e.g., sterilization of the empty barrel and / or plunger) and postfill stages (e.g., external sterilization of the assembled pre-filled syringe). External sterilization typically occurs after the pre-filled syringe has been filled, fully assembled, and located in at least some portion(s) of its final packaging (e.g., a blister pack). For some indications of use, such as certain ophthalmic indications, federal regulations may require external sterilization under certain conditions, parameters, and / or results.

[0004] External sterilization using nitrogen dioxide (NO2), for example, is an effective method of achieving sterility assurance for the external surfaces of a pre-filled syringe combination product while preventing ingress of the sterilant gas (e.g., NO2) to the drug product within the combination product. During an NO2 external sterilization process, the combination products are placed in certain load configurations and loaded into a sterilization chamber. The load configurations can be optimized to ensure sufficient flow of the sterilant gas while also ensuring structural integrity of the loads within the sterilization chamber. One such load configuration includes placing the pre-filled syringes in plastic totes, and stacking and mounting the plastic totes onto a carrier / pallet before loading the totes into a sterilization chamber.

[0005] Using plastic totes to load the combination products within the sterilization chamber, however, may pose some challenges. For example, plastic totes may adsorb and retain the sterilant gas. Accordingly, plastic totes may act as barriers that inhibit sterilant gas flow into and out of the combination product during a sterilization cycle. Moreover, plastic totes may be prone to damage during an external sterilization process, particularly when the load configuration needs to be manually assembled or disassembled. Additionally, the drug product within the combination products may be more prone to spillage while loading the combination products in each individual plastic tote. Finally, in some cases, the physical attributes (e.g., dimensions, geometry, number of structural components, number of flexible barriers, etc.) of plastic totes may pose challenges in optimizing load capacity within a usable volume of a sterilization chamber. Therefore, there is a need for an improved load configuration solutions for external sterilization processing of combination products that optimize sterilant gas flow within the sterilization chamber, optimize load capacity within the sterilization chamber, and ensure structural integrity of the load within the sterilization chamber during an external sterilization process.11105-W001-SEC

[0006] The present disclosure sets forth load configurations and systems embodying advantageous alternatives to existing containers for external sterilization of combination products, and that may address one or more of the challenges or needs mentioned herein, as well as provide other benefits and advantages.SUMMARY

[0007] Various systems for use during an external sterilization process of a plurality of drug delivery devices are provided. One aspect of the present disclosure provides a system for use during an external sterilization process of a plurality of drug delivery devices, the system comprising a tray including at least one partition at least partially enclosed by the tray, and a rack including a metal frame and a plurality of rails fixed to the metal frame. The plurality of rails are configured to support the tray within the rack. The at least one partition defines a plurality of chambers, and each of the plurality of chambers is configured to receive a plurality of drug delivery devices in a front-to-back configuration.

[0008] In some embodiments, the at least one partition may include a plurality of first dividers extending in a first direction and a plurality of second dividers extending in a second direction generally perpendicular to the first direction. Each of the plurality of first dividers may include a first set of metal bars or metal rods extending in the first direction, and each of the plurality of second dividers may include a second set of metal bars or metal rods extending in the second direction generally perpendicular to the first direction. In some embodiments, the at least one partition may include a plurality of openings to permit and / or facilitate distribution of a sterilization gas through the plurality of chambers. The sterilization gas may include nitrogen dioxide. In some embodiments, the tray and the at least one partition may be made of stainless steel, titanium, aluminum, silver, gold, or nitinol. Additionally, or alternatively, the rack may be made of stainless steel.

[0009] In some embodiments, the plurality of drug delivery devices may each include a pre-filled syringe positioned within a blister pack. The pre-filled syringe may include a syringe barrel, a plunger rod, a stopper, and a backstop. The blister pack may include a tray and a cover configured to seal the tray. The cover may be made of a porous material to permit and / or facilitate entry of a sterilization gas through the cover and into the tray of the blister pack. The tray may be gas impermeable to prevent travel of the sterilization gas through the tray. Each of the plurality of chambers may be configured to receive the plurality of drug delivery devices in the front-to-back configuration such that the cover of one of the plurality of drug delivery devices abuts the tray of an adjacent one of the plurality of drug delivery devices.

[0010] In some embodiments, each of the plurality of chambers may be configured to receive at least three drug delivery devices. In some embodiments, each of the plurality of chambers may be configured to receive at least four drug delivery devices. In some embodiments, each of the plurality of chambers may be configured to receive at least five drug delivery devices. In some embodiments, the tray may be configured to receive at least 225 drug delivery devices. In some embodiments, the tray may be configured to receive at least 320 drug delivery devices. In some embodiments, the tray may be configured to receive at least 480 drug delivery devices. In some embodiments, the rack may be configured to support at least 16 trays. In some embodiments, the rack may be configured to support at least 20 trays. In some embodiments, the rack may be configured to support at least 28 trays. In some embodiments, the rack may include a base defining a bottom side thereof, and the base may include a plurality of slots configured to receive at least a portion of a forklift.

[0011] Another aspect of the present disclosure provides system for use during an external sterilization process of a plurality of drug delivery devices, the system comprising a container including an outer housing and at least one partition at least partially enclosed by the outer housing, and a rack including a metal frame and a plurality of rails fixed to the metal frame. The plurality of rails are configured to support the container within the rack. The at least one partition defines a plurality of chambers, and each of the plurality of chambers is configured to receive a plurality of drug delivery devices in a front-to-back configuration.

[0012] In some embodiments, the at least one partition may include a plurality of first dividers extending in a first direction and a plurality of second dividers extending in a second direction generally perpendicular to the first direction. The plurality of11105-W001-SEC first dividers may include a first set of wire mesh sheets, perforated metal sheets, or expanded metal sheets extending in the first direction, and the plurality of second dividers may include a second set of wire mesh sheets, perforated metal sheets, or expanded metal sheets extending in the second direction generally perpendicular to the first direction. In some embodiments, the at least one partition may include a plurality of openings to permit and / or facilitate distribution of a sterilization gas through the plurality of chambers. The sterilization gas may include nitrogen dioxide. In some embodiments, the outer housing and the at least one partition may be made of stainless steel, titanium, aluminum, silver, gold, or nitinol. Additionally, or alternatively, the rack may be made of stainless steel. In some embodiments, the outer housing may be made of one or more wire mesh sheets, perforated metal sheets, or expanded metal sheets, and the outer housing may include a plurality of openings to permit and / or facilitate entry of a sterilization gas into an inner volume of the outer housing.

[0013] In some embodiments, the plurality of drug delivery devices may each include a pre-filled syringe positioned within a blister pack. The pre-filled syringe may include a syringe barrel, a plunger rod, a stopper, and a backstop. The blister pack may include a tray and a cover configured to seal the tray. The cover may be made of a porous material to permit and / or facilitate entry of a sterilization gas through the cover and into the tray of the blister pack. The tray may be gas impermeable to prevent travel of the sterilization gas through the tray. Each of the plurality of chambers may be configured to receive the plurality of drug delivery devices in the front-to-back configuration such that the cover of one of the plurality of drug delivery devices abuts the tray of an adjacent one of the plurality of drug delivery devices.

[0014] In some embodiments, each of the plurality of chambers may be configured to receive at least three drug delivery devices. In some embodiments, the container may include at least two partitions, and the at least two partitions may include a first partition and a second partition stacked on top of the first partition. The first partition and the second partition may be separated by a removable divider made of a wire mesh sheet, a perforated metal sheet, or an expanded metal sheet. In some embodiments, rack may be configured to support 16 containers. In some embodiments, the container may be disposable.

[0015] Yet another aspect of the present disclosure provides a system for use during an external sterilization process of a plurality of drug delivery devices, the system comprising a first container including a first outer housing including a plurality of openings to permit and / or facilitate entry of sterilization gas into an inner volume thereof and at least one partition at least partially enclosed by the outer housing, a second container including a second outer housing, and an interlocking mechanism disposed on the first outer housing and the second outer housing. The interlocking mechanism is configured to removably couple the first container with the second container. In addition, the at least one partition defines a plurality of chambers, and each of the plurality of chambers is configured to receive a plurality of drug delivery devices in a front-to-back configuration.

[0016] In some embodiments, the at least one partition may include a plurality of first dividers extending in a first direction and a plurality of second dividers extending in a second direction generally perpendicular to the first direction. In some embodiments, the plurality of first dividers may include a first set of wire mesh sheets, perforated metal sheets, or expanded metal sheets extending in the first direction, and the plurality of second dividers may include a second set of wire mesh sheets, perforated metal sheets, or expanded metal sheets extending in the second direction generally perpendicular to the first direction. In some embodiments, the at least one partition may include a plurality of openings to permit and / or facilitate distribution of the sterilization gas through the plurality of chambers. The sterilization gas may include nitrogen dioxide. In some embodiments, the first outer housing and the at least one partition may be made of stainless steel, titanium, aluminum, silver, gold, or nitinol. In some embodiments, the first outer housing and the second outer housing may each be made of one or more wire mesh sheets, perforated metal sheets, or expanded metal sheets.

[0017] In some embodiments, the plurality of drug delivery devices may each include a pre-filled syringe positioned within a blister pack. The pre-filled syringe may include a syringe barrel, a plunger rod, a stopper, and a backstop. The blister pack may include a tray and a cover configured to seal the tray. The cover may be made of a porous material to permit and / or facilitate entry of a sterilization gas through the cover and into the tray of the blister pack. The tray may be gas impermeable to prevent11105-W001-SEC travel of the sterilization gas through the tray. Each of the plurality of chambers may be configured to receive the plurality of drug delivery devices in the front-to-back configuration such that the cover of one of the plurality of drug delivery devices abuts the tray of an adjacent one of the plurality of drug delivery devices.

[0018] In some embodiments, the interlocking mechanism may include a protrusion disposed on one of the first outer housing and the second outer housing and a recess disposed on the other one of the first outer housing and the second outer housing. The recess may be configured to receive the protrusion via a snap-fit configuration to removably couple the first container with the second container. In some embodiments, the first container and the second container may be disposable.BRIEF DESCRIPTION OF THE DRAWINGS

[0019] 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 to scale.

[0020] Fig. 1 A is a perspective view of an exemplary tray for use during an external sterilization process of a plurality of drug delivery devices, in accordance with various embodiments of the present disclosure.

[0021] Fig. 1 B is a top view of the exemplary tray shown in Fig. 1A, where the tray includes five drug delivery devices positioned within a chamber of the tray.

[0022] Fig. 2 is a perspective view of an exemplary rack for use during an external sterilization process of a plurality of drug delivery devices, in accordance with various embodiments of the present disclosure.

[0023] Fig. 3 is a top view of an exemplary drug delivery device, more specifically a pre-filled syringe, in accordance with various embodiments of the present disclosure.

[0024] Fig. 4 is a top view of an exemplary drug delivery device, more specifically a pre-filled syringe disposed within a blister pack, in accordance with various embodiments of the present disclosure.

[0025] Fig. 5 is a perspective view of an exemplary system for use during an external sterilization process of a plurality of drug delivery devices, where the system includes a plurality of containers loaded onto a rack, in accordance with various embodiments of the present disclosure.

[0026] Fig. 6A is a top cross-sectional view of an exemplary container of the exemplary system shown in Fig. 5, where the container includes five drug delivery devices positioned within a chamber of the container.

[0027] Fig. 6B is a front cross-sectional view of the exemplary container shown in Fig. 6A.

[0028] Fig. 60 is a side cross-sectional view of the exemplary container shown in Fig. 6A.

[0029] Fig. 7 is a perspective view of another exemplary system for use during an external sterilization process of a plurality of drug delivery devices, where the system includes a plurality of containers, in accordance with various embodiments of the present disclosure.

[0030] Fig. 8 is a perspective view of an exemplary interlocking mechanism for removably coupling two containers within the exemplary system shown in Fig. 7.

[0031] Fig. 9 is a perspective view of another exemplary interlocking mechanism for removably coupling two containers within the exemplary system shown in Fig. 7.

[0032] Fig. 10 is a perspective view of another exemplary tray for use during an external sterilization process of a plurality of drug delivery devices, in accordance with various embodiments of the present disclosure.

[0033] Fig. 11 is a top view of the exemplary tray shown in Fig. 10.

[0034] Fig. 12 is a side view of the exemplary tray shown in Fig. 10.11105-W001-SEC

[0035] Fig. 13 is a perspective view of a portion of the exemplary tray shown in Fig. 10, where the tray includes drug delivery devices positioned within the chambers of the tray.

[0036] Fig. 14 is a perspective view of another exemplary rack for use during an external sterilization process of a plurality of drug delivery devices, in accordance with various embodiments of the present disclosure.

[0037] Fig. 15 is a front view of the exemplary rack shown in Fig. 14.

[0038] Fig. 16 is a side view of the exemplary rack shown in Fig. 14.

[0039] Fig. 17 is a perspective view of an exemplary system for use during an external sterilization process of a plurality of drug delivery devices, where the system includes a plurality of the trays shown in Fig. 10 loaded onto the rack shown in Fig. 14, in accordance with various embodiments of the present disclosure.

[0040] Fig. 18 is another perspective view of the exemplary system shown in Fig. 17.

[0041] Fig. 19 is a perspective view of another exemplary tray for use during an external sterilization process of a plurality of drug delivery devices, in accordance with various embodiments of the present disclosure.

[0042] Fig. 20 is a top view of the exemplary tray shown in Fig. 19.

[0043] Fig. 21 is a bottom view of a portion of the exemplary tray shown in Fig. 19.

[0044] Fig. 22 is a front view of the exemplary tray shown in Fig. 19.

[0045] Fig. 23 is a side view of the exemplary tray shown in Fig. 19.

[0046] Fig. 24 is another top view of the exemplary tray shown in Fig. 19, where the tray includes drug delivery devices positioned within the chambers of the tray.

[0047] Fig. 25 is a front view of the exemplary tray shown in Fig. 24.

[0048] Fig. 26 is a perspective view of another exemplary rack for use during an external sterilization process of a plurality of drug delivery devices, in accordance with various embodiments of the present disclosure.

[0049] Fig. 27 is a bottom perspective view of the exemplary rack shown in Fig. 26.

[0050] Fig. 28 is a front view of the exemplary rack shown in Fig. 26.DETAILED DESCRIPTION

[0051] The present disclosure generally relates to drug delivery devices which can be safely and reliably utilized by a user for administering a drug, or in the case where a patient is the user, self-administering a drug. More particularly, the disclosure generally relates to systems for use during an external sterilization process of the drug delivery devices. As an example, the system may comprise a rack system to support or hold one or more trays containing a plurality of drug delivery devices during at least some steps of the external sterilization process. As another example, the system may comprise a rack system to support or hold one or more containers containing a plurality of drug delivery devices during at least some steps of the external sterilization process. As yet another example, the system may comprise a plurality of containers interlocked with each other via an interlocking mechanism and supporting or holding a plurality of drug delivery devices during at least some steps of the external sterilization process. The drug delivery devices may be in the form of a syringe, such as a pre-filled syringe and / or a pre-filled syringe positioned within primary packaging, such as a blister pack. Utilizing the systems set forth herein, as well as variations of the same, one may be able to optimize sterilant gas flow within the sterilization chamber, optimize load capacity within the sterilization chamber, and ensure structural integrity of the load within the sterilization chamber during an external sterilization process. As used herein, the term “about” means + / - 10% to the smallest significant digit.

[0052] Moreover, the terms “external sterilization” and / or “externally sterilize” as used herein refer to the process of sterilizing a drug delivery device or a combination product after it has been assembled. For example, a pre-filled syringe may be externally sterilized after the syringe, a plunger rod, a backstop, and a protective cap have all been assembled, labeled, and blistered. During the external sterilization process, the pre-filled syringe is typically placed in a sterilization chamber and exposed to a sterilization gas, such as nitrogen dioxide (NO2), for a predetermined length of time and other specified conditions11105-W001-SEC (such as temperature, humidity, and pressure). After the sterilization cycle, the sterilization gas is purged from the chamber, and the pre-filled syringe remains in the chamber for another predetermined length of time and other specified conditions (such as temperature and pressure). While other suitable gas may be used to externally sterilize a drug delivery device, as used herein, the term “sterilization gas” may refer to nitrogen dioxide (NO2).

[0053] Turning to the figures, Figs. 1A and 1 B illustrate an exemplary tray 10 for use during an external sterilization process of a plurality of drug delivery devices 60. The tray 10 includes a bottom tray 12 and at least one partition 14 at least partially enclosed by or otherwise disposed within the bottom tray 12. The bottom tray 12 may include a lip 13 protruding upward along the outer perimeter of the bottom tray 12. The at least one partition 14 may be at least partially surrounded by the lip 13 of the bottom tray 12. The tray 10 shown in Figs. 1A and 1 B is generally rectangular parallelepiped shaped. The tray 10, including the bottom tray 12 and the at least one partition 14, may be made of any rigid material that has a low affinity for nitrogen dioxide adsorption and retention. For example, the tray 10, including the bottom tray 12 and the at least one partition 14, may be made of stainless steel (e.g., austenitic (300-series) stainless steel), titanium, aluminum, silver, gold, or nitinol. Accordingly, the tray 10 may not absorb and retain any sterilant gas when loaded into a sterilization chamber for external sterilization of drug delivery devices supported therein. Moreover, because the tray 10 is made of stainless steel (e.g., austenitic (300-series) stainless steel), titanium, aluminum, silver, gold, or nitinol, the tray 10 may prevent or offer more resistance to damages during an external sterilization process.

[0054] The at least one partition 14 is at least partially enclosed by the bottom tray 12. For example, the partition 14 shown in Figs. 1A and 1 B has a length dimension and a width dimension that are slightly smaller than the corresponding length and width dimensions of the inside of the bottom tray 12. The tray 10, including the bottom tray 12 and the partition 14, may have dimensions that correspond to the size of a rack configured to support the tray 10 and the size of a sterilization chamber so that the tray 10 is able to fit within the sterilization chamber without wasting space. For example, the dimensions of the rack and the dimensions of the tray 10 may be optimized to increase load capacity within the sterilization chamber.

[0055] As shown in Figs. 1A and 1 B, the partition 14 includes a plurality of first dividers 32 each generally extending in a first direction and a plurality of second dividers 34 each generally extending in a second direction that is substantially perpendicular to the first direction. The partition 14 shown in Figs. 1A and 1 B includes three of the plurality of first dividers 32 and three of the plurality of the second dividers 34, but any other suitable number of dividers may be utilized. For example, the partition 14 may include: between 1 and 30 of the plurality of the first dividers 32 and between 1 and 30 of the second dividers 34, between 2 and 20 of the plurality of the first dividers 32 and between 2 and 20 of the second dividers 34, between 3 and 15 of the plurality of the first dividers 32 and between 3 and 15 of the second dividers 34, between 4 and 10 of the plurality of the first dividers 32 and between 4 and 10 of the second dividers 34, or any other suitable number of dividers.

[0056] The first and second dividers 32, 34 cooperate with each other to define chambers 35 configured to receive drug delivery devices 60. For example, the first and second dividers 32, 34 of the partition 14, as shown in Figs. 1A and 1 B, define sixteen (16) chambers 35, but any other suitable number of chambers 35 may be utilized. For example, the partition 14 may define between about 20 and 150 chambers 35, between about 50 and 120 chambers 35, between about 80 and 100 chambers 35, or any other suitable number of chambers 35.

[0057] In the tray 10 shown in Figs. 1Aand 1B, each chamber 35 is configured to receive approximately five (5) drug delivery devices 60 (Fig. 1 B), but any other suitable number of drug delivery devices 60 may be utilized. For example, each chamber 35 may be configured to receive approximately 2 to 20 drug delivery devices 60, 3 to 15 drug delivery devices 60, 4 to 10 drug delivery devices 60, 5 to 8 drug delivery devices, or any other suitable number of drug delivery devices 60. In some embodiments, each tray 10 may be configured to receive at least 320 drug delivery devices 60, at least 480 drug delivery devices 60, at least 495 drug delivery devices, at least 520 drug delivery devices 60, or any other suitable number of drug delivery devices 60.11105-W001-SEC

[0058] Each of the drug delivery devices 60 shown in Figs. 1 A and 1 B includes a pre-filled syringe 50 positioned within a blister pack 61 (Figs. 3-4). As an example, the pre-filled syringe 50 includes a syringe barrel 51, a plunger rod 52, a stopper 53, a luer lock cap 54, and a backstop 55. As an example, the blister pack 61 generally includes a tray 62 and a cover 68 configured to seal the tray 62. As a more specific example, the blister pack 61 may include two pairs of flanges 63, 64, such as snap-fit flanges, to support and / or hold the pre-filled syringe barrel 51 as well as chambers 65, 66, 67 for permitting a user to grip the pre-filled syringe 50 and / or to permit room for components such as the backstop 55. Alternatively or additionally, the pre-filled syringe 50 may be squeezed or pressed out of the tray 62 via the backside of the tray 62.

[0059] The blister pack tray 62 may be coupled with the cover 68. As a more specific example, the blister pack tray 62 may be sealed with the cover 68 after the pre-filled syringe 50 is filled and assembled. The blister pack tray 62 may be made of any suitable material, such as Polyethylene Terephthalate Glycol Copolymer (PETG) and the cover 68 may be made of any suitable material, such as Tyvek or any suitable medical paper. The cover 68 shown in Fig. 4 is made of a material that is gas porous to permit and / or facilitate, during the external sterilization process, entry (and exit) of the sterilization gas (e.g., nitrogen dioxide) into and out of the internal chamber defined by the blister pack tray 62 and the cover 68. As a more specific example, the cover 68 includes micropores such that the cover 68 may be gas permeable to facilitate external sterilization of the pre-filled syringe 50 while it is in the blister pack 60. As an even more specific example, the blister pack tray 62 may not be gas permeable, such that the sterilization gas may travel through the cover 68 but not through the blister pack tray 62.

[0060] As mentioned above, the drug delivery devices 60 shown in Fig. 1 B each include a pre-filled syringe 50 positioned within a blister pack 61 (e.g., the tray 62 which has been sealed with the cover 68) so that the drug delivery devices 60 are ready for the step of external sterilization. As shown in Fig. 1 B, the drug delivery devices 60 are positioned in a front-to-back configuration in the chamber 35. In other words, the drug delivery devices 60 are positioned with respect to each other such that the cover 68 of one device 60 abuts and / or is adjacent to the blister pack tray 62 of an adjacent device. This configuration helps facilitate entry and exit of the sterilization gas into the internal chamber, defined by the blister pack tray 62 and the cover 68, of each drug delivery device 60. As a more specific example, if adjacent devices 60 were arranged such that the respective covers 68 would abut each other, the respective covers could potentially block or prevent entry of sterilization gas into the internal chamber defined by the blister pack tray 62 and the cover 68. However, because adjacent devices 60 are arranged such that the cover 68 of one device 60 abuts and / or is adjacent to the blister pack tray 62 of an adjacent device 60, the sterilization gas can enter the internal chamber of each drug delivery device 60.

[0061] Each of the dividers 32, 34 shown in Fig. 1A includes a plurality of metal bars or metal rods. Each of the metal bars or metal rods may include, but is not limited to, round stock, rod stock, or wire. For example, each of the plurality of first dividers 32 includes a first set of metal bars or rods 32a extending in the first direction, and each of the plurality of second dividers 34 includes a second set of metal bars or rods 34a extending in the second direction substantially perpendicular to the first direction. The first set of metal bars or rods 32a that define one of the first dividers 32 are spaced out from each other such that there is an opening between each of the first set of metal bars or rods 32a. The second set of metal bars or rods 34a that define one of the second dividers 34 are also spaced out from each other such that there is an opening between each of the second set of metal bars or rods 34a. These openings optimize flow of the sterilization gas and help facilitate distribution of the sterilization gas through the plurality of chambers 35 within the tray 10, while also providing a desired amount of structural stability for the tray 10 and / or the drug delivery devices 60 located therein. In some embodiments, the tray 10 may be reusable between different sterilization processes. In other embodiments, the tray 10 may be disposable such that the tray 10 can only be used for a single sterilization process, a two cycle (2X) sterilization process, or a different number of sterilization processes.

[0062] Referring now to Fig. 2, an exemplary rack 20 for supporting the tray 10 is shown. The rack 20 shown in Fig. 2 is generally rectangular parallelepiped shaped having a front side 21, a rear side 24, a left side 22, and a right side 23. The rack 20 includes a metal frame 26 positioned on top of a base 27. As shown in Fig. 2, a plurality of metal rods may be coupled with11105-W001-SEC each other to form the metal frame 26. The rack 20, including the metal frame 26 and / or the base 27, may be made of any rigid material that has a low affinity for nitrogen dioxide adsorption and retention. For example, the rack 20 may be made of stainless steel (e.g., austenitic (300-series) stainless steel), titanium, aluminum, silver, gold, or nitinol. Accordingly, the rack 20 may not absorb and retain any sterilant gas when loaded into a sterilization chamber. Moreover, because the rack 20 is made of stainless steel (e.g., austenitic (300-series) stainless steel), titanium, aluminum, silver, gold, or nitinol, the rack 20 may prevent or offer more resistance to damages during an external sterilization process.

[0063] The rack 20 may further include a plurality of rails 25 extending along the left side 22 and the right side 23 of the rack 20. For example, as shown in Fig. 2, the rails 25 may each extend between the front metal frame 26 and the rear metal frame 26 to define the left side 22 and the right side 23 of the rack 20. The rails 25 may be fixed (e.g., bolted) to the metal frame 26 and configured to hold and support the tray 10 (Figs. 1A-1B) within the rack 20. For example, the tray 10 may be slidably received within the rails 25 so that the tray 10 can be inserted within the rack 20. Each rack 20 may have at least 15 sets of rails 25 such that the rack 20 can support at least 15 trays 10 therein. For example, the rack 20 may have at least 16 sets of rails 25 such that the rack 20 can support at least 16 trays 10 therein, the rack 20 may have at least 17 sets of rails 25 such that the rack 20 can support at least 17 trays 10 therein, the rack 20 may have at least 18 sets of rails 25 such that the rack 20 can support at least 18 trays 10 therein, the rack 20 may have at least 20 sets of rails 25 such that the rack 20 can support at least 20 trays 10 therein, or any suitable number of rails may be utilized.

[0064] As shown in Fig. 2, the base 27 of the rack 20 may include a plurality of slots 28 configured to receive at least a portion of a forklift, or any other machine used to lift and move materials over short distances. Accordingly, once the trays 10 are inserted within the rack 20, the rack 20 can be lifted and moved into a sterilization chamber before an external sterilization process begins, and lifted and moved out of the sterilization chamber after the external sterilization process is complete. This reduces or eliminates the need to individually handle each tray 10, such as manually loading and unloading each tray 10 into and out of the sterilization chamber, thereby optimizing operability, efficiency, and ergonomics. For example, conventional methods of loading drug delivery devices in a sterilization chamber for external sterilization may include manually assembling a plastic tote, keeping the plastic tote stabilized while loading each drug delivery device into the plastic tote, and manually loading individual plastic totes into the sterilization chamber. However, the trays 10 of the present disclosure may be efficiently loaded onto the rack 20, and the rack 20 may be loaded into the sterilization chamber, thereby reducing the need to individually load each tray 10. Moreover, by reducing or eliminating manual handling of each tray 10, the tray 10, as well as the drug delivery devices 60 held therein and the drug product filled within each drug delivery device 60, are less prone to damage and droppage. Moreover, the dimensions of the base 27 and the height of the rack 20 may be optimized to increase load capacity within the usable volume of a sterilization chamber without wasting any space. In some embodiments, the rack 20 may be configured to interface efficiently with a loading system for loading the rack 20 into the sterilization chamber. For example, the base 27 of the rack 20 may include a trolley system with wheels such that the rack 20 can be efficiently and easily loaded into the sterilization chamber without the use of a forklift or any other lifting machine / mechanism.

[0065] In some embodiments, the rack 20 may include designated locations on an external surface thereof to hold or support one or more process challenge devices (PCDs). For example, the rack 20 may include one or more slots on the metal frame 26 to hold or support PCDs. In other embodiments, one or more PCDs may be attached to the metal frame 26 of the rack 20. In some embodiments, each tray 10 may comprise a removable cover configured to protect the drug delivery devices 60 from exposure to light before and / or after a sterilization process. The removable cover may have one or more flaps with hook and loop closure that can be used to removably secure the cover on top of the tray 10. In some embodiments, the removal cover may be configured to protect the entire rack 20 after each tray 10 has been fully assembled and loaded onto the rack 20. The removable cover may have one or more flaps with hook and loop closure that can be used to removably secure the cover on the entire rack 20. In some embodiments, the one or more flaps may be removed to allow for individual or multiple sets of trays11105-W001-SEC 10 to be loaded and unloaded from the rack 20 while ensuring light protection for the remaining loaded trays 10 in the rack 20. In some embodiments, the removable cover may have a slot configured to receive a label and / or a placard. The slot may be used to display the label and / or the placard. The slot may be placed at the base and may further include a flap such that the label and / or the placard to be displayed is at a designated location on the rack 20 and the opening on the cover is to check the label of that particular load.

[0066] Fig. 5 illustrates another exemplary system 70 for use during an external sterilization process of a plurality of drug delivery devices 60. The system 70 comprises a plurality of containers 80 supported within a rack 88. Figs. 6A-6C illustrate top, front, and side views, respectively, of a single container 80. As shown in Figs. 5 and 6A-6C, each container 80 includes an outer housing 82 and at least one partition 90 at least partially enclosed by or otherwise disposed within the outer housing 82. The outer housing 82 is generally rectangular parallelepiped shaped having four side walls 83, 84, 85, 86, a bottom wall (not labeled in Fig. 6B), and a top wall (not labeled in Fig. 6B) cooperating to define an inner volume of the outer housing 82. In some embodiments, the outer housing 82 may be made from one or more wire mesh sheets, perforated metal sheets, or expanded metal sheets and, thus, may include a plurality of openings in the sheets. These openings may permit and / or facilitate entry of sterilization gas into the inner volume of the outer housing 82 and optimize distribution of sterilization gas within the inner volume of the outer housing 82, while also protecting the drug delivery devices 60 inside from exposure to light. The outer housing 82 may be made of any rigid material that has a low affinity for nitrogen dioxide adsorption and retention. For example, the outer housing 82 may be made of stainless steel (e.g., austenitic (300-series) stainless steel), titanium, aluminum, silver, gold, or nitinol. In some embodiments, the containers 80 may be reusable between different sterilization processes. In other embodiments, the containers 80 may be disposable such that the containers 80 can only be used for a single sterilization process, a two cycle (2X) sterilization process, or a different number of sterilization processes.

[0067] As discussed above, each container includes at least one partition 90 (Fig. 6A) at least partially enclosed by or otherwise disposed within the outer housing 82. As best illustrated in Fig. 6A, the partition 90 includes a plurality of first dividers 92 each generally extending in a first direction and a plurality of second dividers 94 each generally extending in a second direction that is substantially perpendicular to the first direction. As a more specific example, the first dividers 92 extend substantially parallel with the side walls 83, 86 and the second dividers 94 extend substantially parallel with the side walls 84, 85. The partition 90 shown in Fig. 6A includes three of the plurality of first dividers 92 and three of the plurality of the second dividers 94, but any other suitable number of dividers may be utilized. For example, the partition 90 may include: between 1 and 30 of the plurality of the first dividers 92 and between 1 and 30 of the second dividers 94, between 2 and 20 of the plurality of the first dividers 92 and between 2 and 20 of the second dividers 94, between 3 and 15 of the plurality of the first dividers 92 and between 3 and 15 of the second dividers 94, between 4 and 10 of the plurality of the first dividers 92 and between 4 and 10 of the second dividers 94, or any other suitable number of dividers.

[0068] As illustrated in Fig. 6A, the first and second dividers 92, 94 cooperate with each other to define chambers 95 configured to receive drug delivery devices 60. For example, the first and second dividers 92, 94 of the partition 90, as shown in Fig. 6A, define sixteen (16) chambers 95, but any other suitable number of chambers 95 may be utilized. For example, the partition 90 may define between about 20 and 150 chambers 95, between about 50 and 120 chambers 95, between about 80 and 100 chambers 95, or any other suitable number of chambers 95. In some embodiments, the first and second dividers 92, 94 may each include a plurality of openings to permit and / or facilitate distribution of the sterilization gas through the chambers 95 within the partition 90. For example, each chamber 95 may include at least one opening on each side thereof to distribute the sterilization gas through the chambers 95 within the partition 90. In some embodiments, the first and second dividers 92, 94 of the partition 90 may each be made of a wire mesh sheet, a perforated metal sheet, or an expanded metal sheet and, thus, include a plurality of openings in the sheet to optimize and facilitate distribution of the sterilization gas through the chambers 95 within the partition 90.11105-W001-SEC

[0069] In the container 80 shown in Fig. 6A, each chamber 95 is configured to receive approximately five (5) drug delivery devices 60, but any other suitable number of drug delivery devices 60 may be utilized. For example, each chamber 95 may be configured to receive approximately 2 to 20 drug delivery devices 60, 3 to 15 drug delivery devices 60, 4 to 10 drug delivery devices 60, 5 to 8 drug delivery devices, or any other suitable number of drug delivery devices 60. In some embodiments, each container 80 may be configured to receive at least 320 drug delivery devices 60, at least 480 drug delivery devices 60, at least 495 drug delivery devices, at least 520 drug delivery devices 60, or any other suitable number of drug delivery devices 60. Similar to the outer housing 82, the partition 90 may be made of any rigid material that has a low affinity for nitrogen dioxide adsorption and retention. For example, the partition 90 may be made of stainless steel (e.g., austenitic (300-series) stainless steel), titanium, aluminum, silver, gold, or nitinol.

[0070] As shown in Fig. 6A, the drug delivery devices 60 are positioned in a front-to-back configuration in the chamber 95. In other words, the drug delivery devices 60 are positioned with respect to each other such that the cover 68 (Fig. 4) of one device 60 abuts and / or is adjacent to the blister pack tray 62 (Fig. 4) of an adjacent device 60. As discussed above, this configuration helps facilitate entry and exit of the sterilization gas into the internal chamber, defined by the blister pack tray 62 and the cover 68, of each drug delivery device 60.

[0071] Referring to Figs. 6B and 6C, each container 80 may include a plurality of partitions 90 stacked vertically on top of each other. For example, the container 80 shown in Figs. 6B and 6C includes four (4) partitions 90a, 90b, 90c, 90d stacked vertically on top of each other and separated by removable level dividers 96. The partitions 90a, 90b, 90c, 90d are each similar or identical to each other and the level dividers 96 are each similar or identical to each other such that each partition 90a, 90b, 90c, 90d is able to support and hold the same number of drug delivery devices 60. As one specific example, the partition 90a shown in Fig. 6B includes sixteen (16) chambers 95, and each chamber 95 is able to support and hold five (5) drug delivery devices 60, so that partition 90a is able to support and hold up to 80 drug delivery devices 60. Therefore, each of the subsequent partitions 90b, 90c, 90d each is also able to support and hold up to 80 drug delivery devices 60, for a total of 320 drug delivery devices 60 (e.g., 80 * 4 = 320) in each container 80.

[0072] The level dividers 96 may each include a plurality of openings that permit and facilitate distribution of the sterilization gas between the various partitions 90a, 90b, 90c, 90d. In some embodiments, the level dividers 96 may each be made of a wire mesh sheet, a perforated metal sheet, or an expanded metal sheet and include a plurality of openings in the sheet to permit and facilitate distribution of the sterilization gas between the various partitions 90a, 90b, 90c, 90d. Similar to the partition 90, the level dividers 96 may be made of any rigid material that has a low affinity for nitrogen dioxide adsorption and retention. For example, the level dividers 96 may be made of stainless steel (e.g., austenitic (300-series) stainless steel), titanium, aluminum, silver, gold, or nitinol.

[0073] Referring back to Fig. 5, the rack 88 may be configured to hold and support the containers 80. The rack 88 shown in Fig. 5 is generally rectangular parallelepiped shaped having a front side 71 , a rear side 74, a left side 72, and a right side 73. The rack 88 includes a metal frame 76 positioned on top of a base 77. As shown in Fig. 5, a plurality of metal rods may be coupled with each other to form the metal frame 76. The rack 88, including the metal frame 76 and / or the base 77, may be made of any rigid material that has a low affinity for nitrogen dioxide adsorption and retention. For example, the rack 88 may be made of stainless steel (e.g., austenitic (300-series) stainless steel), titanium, aluminum, silver, gold, or nitinol.

[0074] The rack 88 may further include a plurality of rails 75 extending along the left side 72 and the right side 73 of the rack 88. The rails 75 may be fixed (e.g., bolted) to the metal frame 76 and configured to hold and support the containers 80 within the rack 88. For example, each container 80 may be slidably received within the rails 75 so that each container 80 can be inserted within the rack 88. Each container 80 may have its own set of two rails 75 within the rack 88 that is configured to slidably receive each container 80. In some embodiments, the rack 88 may have at least 16 sets of rails 75 such that the rack 88 can support at least 16 containers 80 therein. In other embodiments, the rack 88 may have at least 17 sets of rails 75 such11105-W001-SEC that the rack 88 can support at least 17 containers 80 therein, the rack 88 may have at least 18 sets of rails 75 such that the rack 88 can support at least 18 containers 80 therein, the rack 88 may have at least 20 sets of rails 75 such that the rack 88 can support at least 20 containers 80 therein, or any suitable number of rails may be utilized.

[0075] As shown in Fig. 5, the base 77 of the rack 88 may include a plurality of slots 78 configured to receive at least a portion of a forklift, or any other machine used to lift and move materials over short distances. Accordingly, once the containers 80 are inserted within the rack 88, the rack 88 can be lifted and moved into a sterilization chamber before an external sterilization process begins, and lifted and moved out of the sterilization chamber after the external sterilization process is complete. This reduces or eliminates the need to individually handle each container 80, such as manually loading and unloading each container 80 into and out of the sterilization chamber, thereby improving and optimizing operability, efficiency, and ergonomics. For example, conventional methods of loading drug delivery devices in a sterilization chamber for external sterilization may include manually assembling a plastic tote, keeping the plastic tote stabilized while loading each drug delivery device into the plastic tote, and manually loading individual plastic totes into the sterilization chamber. However, the container 80 of the present disclosure may be efficiently loaded onto the rack 88, and the rack 88 may be loaded into the sterilization chamber, thereby reducing the need to individually load each container 80. Moreover, by reducing or eliminating manual handling of each container 80, the containers 80, as well as the drug delivery devices 60 contained therein and the drug product filled within each drug delivery device 60, are less prone to damage and droppage. Moreover, the dimensions of the base 77 and the height of the rack 88 may be optimized to increase load capacity within the usable volume of a sterilization chamber without wasting any space. In some embodiments, the rack 88 may be configured to interface efficiently with a loading system for loading the rack 88 into the sterilization chamber. For example, the base 77 of the rack 88 may include a trolley system with wheels such that the rack 88 can be efficiently and easily loaded into the sterilization chamber without the use of a forklift or any other lifting machine / mechanism.

[0076] In some embodiments, the rack 88 may include designated locations on an external surface thereof to hold or support one or more process challenge devices (PCDs). For example, the rack 88 may include one or more slots on the metal frame 76 to hold or support PCDs. In other embodiments, one or more PCDs may be attached to the metal frame 76 of the rack 88.

[0077] Fig. 7 illustrates another exemplary system 100 for use during an external sterilization process of a plurality of drug delivery devices 60. The system 100 comprises a plurality of containers 101 each including an outer housing 102. Similar to the outer housing 82 of the containers 80, the outer housing 102 of each container 101 may be generally rectangular parallelepiped shaped having four side walls, a bottom wall, and a top wall cooperating to define an inner volume of the outer housing 102. In some embodiments, the outer housing 102 may be made of one or more wire mesh sheets, perforated metal sheets, or expanded metal sheets and, thus, include a plurality of openings in the sheets. These openings permit and / or facilitate entry of sterilization gas into the inner volume of the outer housing 102 and optimize distribution of sterilization gas within the inner volume of the outer housing 102, while also protecting the drug delivery devices 60 inside from exposure to light. The outer housing 102 may be made of any rigid material that has a low affinity for nitrogen dioxide adsorption and retention. For example, the outer housing 102 may be made of stainless steel (e.g., austenitic (300-series) stainless steel), titanium, aluminum, silver, gold, or nitinol. In some embodiments, the containers 101 may be reusable between different sterilization processes. In other embodiments, the containers 101 may be disposable such that the containers 101 can only be used for a single sterilization process, a two cycle (2X) sterilization process, or a different number of sterilization processes. Moreover, in some embodiments, the outer housing 102 of the container 101 may include a designated location to hold or support one or more process challenge devices (PCDs). For example, the outer housing 102 may include one or more slots on an external surface thereof to hold or support PCDs.

[0078] Each container 101 of the system 100 may also include at least one partition 90 (shown in Figs. 6A-6C) at least partially enclosed by or otherwise disposed within the outer housing 102. As discussed above, the partition 90 includes a11105-W001-SEC plurality of first dividers 92 each generally extending in a first direction and a plurality of second dividers 94 each generally extending in a second direction that is substantially perpendicular to the first direction. The dividers of the partition 90 may cooperate with each other to define chambers 95 configured to receive drug delivery devices 60 (shown in Fig. 4). In some embodiments, the dividers of the partition 90 may each include a plurality of openings to permit and / or facilitate distribution of the sterilization gas through the chambers 95 within the partition 90. For example, each chamber 95 may include at least one opening on each side thereof to distribute the sterilization gas through the chambers 95 within the partition 90. In other embodiments, the dividers of the partition 90 may each be made of a wire mesh sheet, a perforated metal sheet, or an expanded metal sheet and include a plurality of openings in the sheet to optimize and facilitate distribution of the sterilization gas through the chambers 95 within the partition 90. Similar to the outer housing 102, the partition 90 disposed within the outer housing 102 of each container 101 may be made of any rigid material that has a low affinity for nitrogen dioxide adsorption and retention. For example, the partition 90 may be made of stainless steel (e.g., austenitic (300-series) stainless steel), titanium, aluminum, silver, gold, or nitinol.

[0079] As shown in Fig. 6A, for example, the drug delivery devices 60 held within the chambers 95 of the partition 90 are positioned in a front-to-back configuration. In other words, the drug delivery devices 60 are positioned with respect to each other such that the cover 68 (Fig. 4) of one device 60 abuts and / or is adjacent to the blister pack tray 62 (Fig. 4) of an adjacent device 60. As discussed above, this configuration helps facilitate entry and exit of the sterilization gas into the internal chamber, defined by the blister pack tray 62 and the cover 68, of each drug delivery device 60.

[0080] In some embodiments, each container 101 of the system 100 may include a plurality of partitions 90 stacked vertically on top of each other. For example, similar to the container 80 in Figs. 6B and 6C, the container 101 may include four (4) partitions 90a, 90b, 90c, 90d stacked vertically on top of each other and separated by removable level dividers 96. The partitions 90a, 90b, 90c, 90d are each similar or identical to each other and the level dividers 96 are each similar or identical to each other such that each partition 90a, 90b, 90c, 90d is able to support and hold the same number of drug delivery devices 60. The level dividers 96 may each include a plurality of openings that permit and facilitate distribution of the sterilization gas between the various partitions 90a, 90b, 90c, 90d. In some embodiments, the level dividers 96 may each be made of a wire mesh sheet, a perforated metal sheet, or an expanded metal sheet and include a plurality of openings in the sheet to permit and facilitate distribution of the sterilization gas between the various partitions 90a, 90b, 90c, 90d. Similar to the partition 90, the level dividers 96 may be made of any rigid material that has a low affinity for nitrogen dioxide adsorption and retention. For example, the level dividers 96 may be made of stainless steel (e.g., austenitic (300-series) stainless steel), titanium, aluminum, silver, gold, or nitinol.

[0081] Referring back to Fig. 7, the system 100 may comprise a base 107 and a plurality of containers 101 disposed on top of the base 107. In other embodiments, the system 100 may not comprise a base 107, and the plurality of containers 101 may be stacked without the base 107. The base 107 may include a plurality of slots 108 configured to receive at least a portion of a forklift, or any other machine used to lift and move materials over short distances. Accordingly, once the containers 101 are loaded onto the base 107 of the system 100, the base 107 (along with the containers 101 loaded on top) can be lifted and moved into a sterilization chamber before an external sterilization process begins, and lifted and moved out of the sterilization chamber after the external sterilization process is complete. This reduces or eliminates the need to individually handle each container 101, such as manually loading and unloading each container 101 into and out of the sterilization chamber, thereby optimizing operability, efficiency, and ergonomics. For example, conventional methods of loading drug delivery devices in a sterilization chamber for external sterilization may include manually assembling a plastic tote, keeping the plastic tote stabilized while loading each drug delivery device into the plastic tote, and manually loading individual plastic totes into the sterilization chamber. However, the containers 101 of the present disclosure may be stacked onto the base 107 of the system 100 and simultaneously loaded into the sterilization chamber, thereby reducing the need to individually load each container 101.11105-W001-SEC Moreover, by reducing or eliminating manual handling of each container 101, the containers 101, as well as the drug delivery devices 60 contained therein and the drug product filled within each drug delivery device 60, are less prone to damage and droppage. Moreover, the dimensions of the base 107 may be optimized to increase load capacity within the usable volume of a sterilization chamber without wasting any space. In some embodiments, the base 107 may be configured to interface efficiently with a loading system for loading the containers 101 into the sterilization chamber. For example, the base 107 may include a trolley system with wheels such that the containers 101 can be simultaneously and efficiently loaded into the sterilization chamber without the use of a forklift or any other lifting machine / mechanism. In some embodiments, the base 107 may be made of any rigid material that has a low affinity for nitrogen dioxide adsorption and retention. For example, the base 107 may be made of stainless steel (e.g., austenitic (300-series) stainless steel), titanium, aluminum, silver, gold, or nitinol.

[0082] As illustrated in Fig. 7, the plurality of containers 101 may be stacked vertically on top of each other, and the stacks of containers 101 may be disposed adjacent to each other on the base 107. While Fig. 7 illustrates four (4) vertical stacks of four (4) containers 101 in each stack, any suitable number of containers 101 and / or stacks of containers 101 may be utilized in the system 100. Moreover, while the containers 101 in Fig. 7 are vertically stacked on top of each other, in some embodiments, the containers 101 may be rotated (e.g., rotated by 90° to avoid continuous vertical stacking). By way of example, the bottommost container 101 in each stack may be disposed on the base 107, the second bottommost container 101 may be rotated by 90° relative to the bottommost container 101 prior to stacking on top of the bottommost container 101, and the third bottommost container 101 may be rotated again by 90° relative to the second bottommost container 101 prior to stacking on top of the second bottommost container 101.

[0083] In one embodiment, as shown in Fig. 8, the system 100 may comprise an interlocking mechanism 110a disposed on each container 101 to ensure the containers 101 are removably coupled with each other, thereby improving structural integrity and stability of the system 100 during the external sterilization process. For example, each container 101 may include interface features positioned along one or more portions of the outer housing 102, including but not limited to the side walls, the bottom wall, and / or the top wall. As one specific example, the containers 101 may each include a plurality of recesses 114 on a top wall thereof and a plurality of protrusions 112 disposed on a bottom wall thereof. When stacking one of the containers 101 (i.e., top container 101a) on top of an adjacent one of the containers 101 (i.e., bottom container 101b), the recesses 114 of the bottom container 101b may be configured to receive the protrusions 112 of the top container 101a via, for example, a snap-fit configuration to removably couple the top container 101a with the bottom container 101b. Although not shown in Fig. 8, each container 101 may include the interlocking mechanism 110a on the side walls thereof so as to removably couple not only vertically adjacent containers 101 but also horizontally adjacent containers 101 with each other. For example, each container 101 may include a plurality of recesses 114 on a first side wall thereof and a plurality of protrusions 112 on a second side wall thereof that is opposite to the first side wall. Accordingly, the recesses 114 of one container 101 may be configured to receive the protrusions 112 on a horizontally adjacent container 101 to removably couple horizontally adjacent containers 101 in the system 100.

[0084] In another exemplary embodiment, as shown in Fig. 9, the system 100 may comprise an interlocking mechanism 110b disposed on each container 101 to ensure the containers 101 are removably coupled with each other, thereby improving structural integrity and stability of the system 100 during the external sterilization process. For example, the containers 101 may each include a plurality of channels 118 on opposite sides of a top wall thereof and a plurality of bars 116 disposed on opposite sides of a bottom wall thereof. When stacking one of the containers 101 (i.e., top container 101a) on top of an adjacent one of the containers 101 (i.e., bottom container 101b), the channels 118 of the bottom container 101b may be configured to slidably receive the bars 116 of the top container 101a via, for example, a friction-fit configuration to removably couple the top container 101a with the bottom container 101b.11105-W001-SEC

[0085] Additionally, or alternatively, each container 101 may further comprise a clamping mechanism configured to removably clamp together adjacent walls of adjacent containers 101 and / or corner interfaces in the adjacent containers 101 in the vertical and / or horizontal directions. The clamping mechanism may provide additional structural stability to the stacked containers 101.

[0086] In some embodiments, the containers 101 of the system 100 may be modular units. Accordingly, each individual container 101 may be removably coupled with each other and may be reconfigured / repositioned at any point during the external sterilization process. For example, during shipping of the containers 101, one or more containers 101 of the system 100 may be removed or reconfigured to fit a standard pallet. Subsequently, the one or more containers 101 may be reconfigured prior to placing the system 100 into an internal volume of a sterilization chamber to optimize load capacity within the usable volume of a sterilization chamber without wasting any space. Moreover, if one of the containers 101 is damaged during shipping or handling, the damaged container can be easily replaced due to the modular configuration of the containers 101.

[0087] Figs. 10-13 illustrate another exemplary tray 210 for use during an external sterilization process of a plurality of drug delivery devices 60. The tray 210 includes a bottom tray 212 and at least one partition 214 coupled to the bottom tray 212. The bottom tray 212 may include a lip 213 protruding upward along the outer perimeter of the bottom tray 212. As shown in Figs. 10 and 12, the at least one partition 214 may include a plurality of metal bars or rods 214a, 214b, 214c, 214d that define an outer perimeter of the at least one partition 214. Each of the metal bars or rods 214a, 214b, 214c, 214d may include, but is not limited to round stock, rod stock, or wire. The plurality of metal bars or rods 214a, 214b, 214c, 214d may be coupled to each other by a plurality of vertical supporting rods 233 positioned around the at least one partition 214. For example, the plurality of metal bars or rods 214a, 214b, 214c, 214d may be welded to the plurality of vertical supporting rods 233, and the plurality of supporting rods 233 may be welded to the bottom tray 212 such that the at least one partition 214 is coupled to the bottom tray 212. The tray 210 shown in Figs. 10-13 is generally rectangular parallelepiped shaped. The tray 210, including the bottom tray 212 and the at least one partition 214, may be made of any rigid material that has a low affinity for nitrogen dioxide adsorption and retention. For example, the tray 210, including the bottom tray 212 and the at least one partition 214, may be made of stainless steel (e.g., austenitic (300-series) stainless steel), titanium, aluminum, silver, gold, or nitinol. Accordingly, the tray 210 may not absorb and retain any sterilant gas when loaded into a sterilization chamber for external sterilization of drug delivery devices supported therein. Moreover, because the tray 210 is made of stainless steel (e.g., austenitic (300-series) stainless steel), titanium, aluminum, silver, gold, or nitinol, the tray 210 may prevent or offer more resistance to damages during an external sterilization process.

[0088] As shown in Fig. 11, the bottom tray 212 maybe at least partially enclosed by the at least one partition 214. For example, the bottom tray 212 may have a length dimension and a width dimension that are slightly smaller than the corresponding length and width dimensions of the partition 214. The tray 210, including the bottom tray 212 and the partition 214, may have dimensions that correspond to the size of a rack configured to support the tray 210 and the size of a sterilization chamber so that the tray 210 is able to fit within the sterilization chamber without wasting space. For example, the dimensions of the rack and the dimensions of the tray 210 may be optimized to increase load capacity within the sterilization chamber.

[0089] As shown in Figs. 10-13, the partition 214 includes a plurality of first dividers 232 each generally extending in a first direction and a plurality of second dividers 234 each generally extending in a second direction that is substantially perpendicular to the first direction. The partition 214 shown in Figs. 10-12 includes four of the plurality of first dividers 232 and eight of the plurality of the second dividers 234, but any other suitable number of dividers may be utilized. For example, the partition 214 may include: between 1 and 30 of the plurality of the first dividers 232 and between 1 and 30 of the second dividers 234, between 2 and 20 of the plurality of the first dividers 232 and between 2 and 20 of the second dividers 234, between 3 and 15 of the plurality of the first dividers 232 and between 3 and 15 of the second dividers 234, between 4 and 1011105-W001-SEC of the plurality of the first dividers 232 and between 4 and 10 of the second dividers 234, or any other suitable number of dividers.

[0090] The first and second dividers 232, 234 cooperate with each other to define chambers 235 configured to receive drug delivery devices 60. For example, the first and second dividers 232, 234 of the partition 214, as shown in Fig. 11, define forty-five (45) chambers 235, but any other suitable number of chambers 235 may be utilized. For example, the partition 214 may define between about 20 and 150 chambers 235, between about 50 and 120 chambers 235, between about 80 and 100 chambers 235, or any other suitable number of chambers 235.

[0091] In the tray 210 shown in Fig. 11, each chamber 235 may be configured to receive approximately five (5) drug delivery devices 60 such that each tray 210 is configured to receive up to 225 drug delivery devices 60. However, any other suitable number of drug delivery devices 60 may be utilized. For example, each chamber 235 may be configured to receive approximately 2 to 20 drug delivery devices 60, 3 to 15 drug delivery devices 60, 4 to 10 drug delivery devices 60, 5 to 8 drug delivery devices, or any other suitable number of drug delivery devices 60. In some embodiments, each tray 210 may be configured to receive at least 200 drug delivery devices 60, at least 225 drug delivery devices 60, at least 320 drug delivery devices 60, at least 480 drug delivery devices 60, at least 495 drug delivery devices, at least 520 drug delivery devices 60, or any other suitable number of drug delivery devices 60.

[0092] As shown in Figs. 11 and 13, each chamber 235 may be configured to receive approximately five (5) drug delivery devices 60, although any other suitable number of drug delivery devices 60 may be utilized. Each of the drug delivery devices 60 shown in Fig. 13 includes a pre-filled syringe 50 positioned within a blister pack 61 (Figs. 3-4). The blister pack 61 generally includes a tray 62 and a cover 68 configured to seal the tray 62. The blister pack tray 62 may be coupled with the cover 68. As a more specific example, the blister pack tray 62 may be sealed with the cover 68 after the pre-filled syringe 50 is filled and assembled. The blister pack tray 62 may be made of any suitable material, such as Polyethylene Terephthalate Glycol Copolymer (PETG) and the cover 68 may be made of any suitable material, such as Tyvek or any suitable medical paper. The cover 68 is made of a material that is gas porous to permit and / or facilitate, during the external sterilization process, entry (and exit) of the sterilization gas (e.g., nitrogen dioxide) into and out of the internal chamber defined by the blister pack tray 62 and the cover 68. As a more specific example, the cover 68 includes micropores such that the cover 68 may be gas permeable to facilitate external sterilization of the pre-filled syringe 50 while it is in the blister pack 60. As an even more specific example, the blister pack tray 62 may not be gas permeable, such that the sterilization gas may travel through the cover 68 but not through the blister pack tray 62.

[0093] As mentioned above, the drug delivery devices 60 shown in Fig. 13 each include a pre-filled syringe 50 positioned within a blister pack 61 (e.g., the tray 62 which has been sealed with the cover 68) so that the drug delivery devices 60 are ready for the step of external sterilization. As shown in Fig. 13, the drug delivery devices 60 are positioned vertically in a front-to-back configuration in the chamber 235. In other words, the drug delivery devices 60 are positioned vertically with respect to each other such that the cover 68 of one device 60 abuts and / or is adjacent to the blister pack tray 62 of an adjacent device. This front-to-back configuration helps facilitate entry and exit of the sterilization gas into the internal chamber, defined by the blister pack tray 62 and the cover 68, of each drug delivery device 60. As a more specific example, if adjacent devices 60 were arranged such that the respective covers 68 would abut each other, the respective covers could potentially block or prevent entry of sterilization gas into the internal chamber defined by the blister pack tray 62 and the cover 68. However, because adjacent devices 60 are arranged such that the cover 68 of one device 60 abuts and / or is adjacent to the blister pack tray 62 of an adjacent device 60, the sterilization gas can enter the internal chamber of each drug delivery device 60.

[0094] The dividers 232, 234 shown in Figs. 10-13 include a plurality of metal bars or rods. Each of the metal bars or rods may include, but is not limited to, round stock, rod stock, or wire. For example, the plurality of first dividers 232 includes a first set of metal bars or rods extending in the first direction, and the plurality of second dividers 234 includes a second set of metal11105-W001-SEC bars or rods extending in the second direction substantially perpendicular to the first direction. The plurality of metal bars or rods that define the first dividers 232 in the tray 210 and the plurality of metal bars or rods that define the second dividers 234 are spaced out from each other such that there is an opening between any two of the wires. These openings optimize flow of the sterilization gas and help facilitate distribution of the sterilization gas through the plurality of chambers 235 within the tray 210, while also providing a desired amount of structural stability for the tray 210 and / or the drug delivery devices 60 located therein. In some embodiments, the tray 210 may be reusable between different sterilization processes. In other embodiments, the tray 210 may be disposable such that the tray 210 can only be used for a single sterilization process, a two cycle (2X) sterilization process, or a different number of sterilization processes. In some embodiments, the bottom tray 212 may be made of a wire mesh to optimize flow of the sterilization gas through the openings within the wire mesh and help facilitate distribution of the sterilization gas through the plurality of chambers 235 within the tray 210. Moreover, when a plurality of the trays 210 are loaded onto a rack, as discussed in more detail below, the wire mesh will optimize flow of the sterilization gas from one tray 210 to another tray 210 within the rack and help facilitate distribution of the sterilization gas within a sterilization chamber. In some embodiments, the bottom tray 212 may be made of interwoven metal bars or metal rods. In other embodiments, the bottom tray 212 may be made of parallel metal bars or metal rods to provide lateral retention of the drug delivery devices 60 within the tray 210 such that the drug delivery devices 60 do not slide down when loading the tray 210 onto a rack.

[0095] Referring now to Figs. 14-18, an exemplary rack 220 for supporting a plurality of the trays 210 is shown. The rack 220 is generally rectangular parallelepiped shaped having a front side 221, a rear side 224, a left side 222, and a right side 223. The rack 220 includes a metal frame 226 positioned on top of a base 227. As shown in Fig. 14, a plurality of metal rods may be coupled with each other to form the metal frame 226. The base 227 may include a plurality of base frames 227a, 227b, 227c, 227d configured to support the metal frame 226. The plurality of base frames 227a, 227b, 227c, 227d may be coupled to the metal frame 226, for example, via welding or bolting. The rack 220, including the metal frame 226 and / or the base 227, may be made of any rigid material that has a low affinity for nitrogen dioxide adsorption and retention. For example, the rack 220 may be made of stainless steel (e.g., austenitic (300-series) stainless steel), titanium, aluminum, silver, gold, or nitinol. Accordingly, the rack 220 may not absorb and retain any sterilant gas when loaded into a sterilization chamber for external sterilization of drug delivery devices supported therein. Moreover, because the rack 220 is made of stainless steel (e.g., austenitic (300-series) stainless steel), titanium, aluminum, silver, gold, or nitinol, the rack 220 may prevent or offer more resistance to damages during an external sterilization process.

[0096] As shown in Figs. 14-16, the rack 220 may further include a plurality of rails 225 extending from the front side 221 of the rack 220 to the rear side 224 of the rack 220. The rails 225 may be fixed (e.g., bolted) to the metal frame 226 and configured to hold and support a plurality of the trays 210 within the rack 220, as shown in Figs. 17 and 18. For example, each of the trays 210 may be slidably received within a pair of rails 225 so that the trays 210 can be loaded onto into individual locations within the rack 220. As shown in Figs. 14-16, each rack 220 may have at least 28 pairs of rails 225 such that at least 28 trays 210 can be loaded onto each rack 220. Because each tray 210 shown in Figs. 10-13 is configured to receive up to 225 drug delivery devices 60 therein, the rack 220 shown in Figs. 14-16 may be configured to hold up to 6300 drug delivery devices 60 when trays 210 are loaded onto each pair of rails 225 within the rack 220 (as shown in Fig. 18). In some embodiments, the rack 220 may have at least 30 pairs of rails 225 such that the rack 220 can support at least 30 trays 210 therein, the rack 220 may have at least 32 pairs of rails 225 such that the rack 220 can support at least 32 trays 210 therein, or any suitable number of rails 225 may be utilized.

[0097] As shown in Figs. 14 and 16-18, the plurality of base frames 227a, 227b, 227c, 227d that define the base 227 of the rack 220 may each have an opening configured to receive at least a portion of a forklift, or any other machine used to lift and move materials over short distances. Accordingly, once the trays 210 are inserted within the rack 220, the rack 220 can be lifted and moved into a sterilization chamber before an external sterilization process begins, and lifted and moved out of the11105-W001-SEC sterilization chamber after the external sterilization process is complete. This reduces or eliminates the need to individually handle each tray 210, such as manually loading and unloading each tray 210 into and out of the sterilization chamber, thereby optimizing operability, efficiency, and ergonomics. For example, conventional methods of loading drug delivery devices in a sterilization chamber for external sterilization may include manually assembling a plastic tote, keeping the plastic tote stabilized while loading each drug delivery device into the plastic tote, and manually loading individual plastic totes into the sterilization chamber. However, the trays 210 of the present disclosure may be efficiently loaded onto the rack 220, and the rack 220 may be loaded into the sterilization chamber, thereby reducing the need to individually load each tray 210. Moreover, by reducing or eliminating manual handling of each tray 210, the tray 210, as well as the drug delivery devices 60 held therein and the drug product filled within each drug delivery device 60, are less prone to damage and droppage. Moreover, the dimensions of the base 227 and the height of the rack 220 may be optimized to increase load capacity within the usable volume of a sterilization chamber without wasting any space.

[0098] In some embodiments, the rack 220 may include designated locations on an external surface thereof to hold or support one or more process challenge devices (PCDs). For example, the rack 220 may include one or more slots on the metal frame 226 to hold or support PCDs. In other embodiments, one or more PCDs may be attached to the metal frame 226 of the rack 220. In some embodiments, each tray 210 may comprise a removable cover configured to protect the drug delivery devices 60 from exposure to light before and / or after a sterilization process. The removable cover may have one or more flaps with hook and loop closure that can be used to removably secure the cover on top of the tray 210. In some embodiments, the removal cover may be configured to protect the entire rack 220 after each tray 210 has been fully assembled and loaded onto the rack 220. The removable cover may have one or more flaps with hook and loop closure that can be used to removably secure the cover on the entire rack 220. In some embodiments, the one or more flaps may be removed to allow for individual or multiple sets of trays 210 to be loaded and unloaded from the rack 220 while ensuring light protection for the remaining loaded trays 210 in the rack 220. In some embodiments, the removable cover may have a slot configured to receive a label and / or a placard. The slot may be used to display the label and / or the placard. The slot may be placed at the base and may further include a flap such that the label and / or the placard to be displayed is at a designated location on the rack 220 and the opening on the cover is to check the label of that particular load.

[0099] Figs. 19-25 illustrate another exemplary tray 310 for use during an external sterilization process of a plurality of drug delivery devices 60. The tray 310 includes a bottom tray 312 and at least one partition 314 coupled to the bottom tray 312. The at least one partition 314 may include a plurality of metal bars or rods 314a, 314b, 314c that define an outer perimeter of the at least one partition 314. Each of the metal bars or rods 314a, 314b, 314c may include, but is not limited to, round stock, rod stock, or wire. The plurality of metal bars or rods 314a, 314b, 314c may be coupled to each other by a plurality of vertical supporting rods 333 positioned around the at least one partition 314. For example, the plurality of metal bars or rods 314a, 314b, 314c may be welded to the plurality of vertical supporting rods 333, and the plurality of supporting rods 333 may be welded to the bottom tray 312 such that the at least one partition 314 is coupled to the bottom tray 312. The tray 310 shown in Figs. 19-25 is generally rectangular parallelepiped shaped. The tray 310, including the bottom tray 312 and the at least one partition 314, may be made of any rigid material that has a low affinity for nitrogen dioxide adsorption and retention. For example, the tray 310, including the bottom tray 312 and the at least one partition 314, may be made of stainless steel (e.g., austenitic (300-series) stainless steel), titanium, aluminum, silver, gold, or nitinol. Accordingly, the tray 310 may not absorb and retain any sterilant gas when loaded into a sterilization chamber for external sterilization of drug delivery devices supported therein. Moreover, because the tray 310 is made of stainless steel (e.g., austenitic (300-series) stainless steel), titanium, aluminum, silver, gold, or nitinol, the tray 310 may prevent or offer more resistance to damages during an external sterilization process.11105-W001-SEC

[0100] As shown in Fig. 20, the bottom tray 312 may be at least partially enclosed by the at least one partition 314. For example, the bottom tray 312 may have a length dimension and a width dimension that are slightly smaller than the corresponding length and width dimensions of the partition 314. The tray 310, including the bottom tray 312 and the partition 314, may have dimensions that correspond to the size of a rack configured to support the tray 310 and the size of a sterilization chamber so that the tray 310 is able to fit within the sterilization chamber without wasting space. For example, the dimensions of the rack and the dimensions of the tray 310 may be optimized to increase load capacity within the sterilization chamber.

[0101] As shown in at least Figs. 19, 20, 22, 23, 24, and 25, the partition 314 includes a plurality of first dividers 332 each generally extending in a first direction and a plurality of second dividers 334 each generally extending in a second direction that is substantially perpendicular to the first direction. The partition 314 shown in Figs. 19, 20, 22, 23, 24, and 25 includes four of the plurality of first dividers 332 and eight of the plurality of the second dividers 334, but any other suitable number of dividers may be utilized. For example, the partition 314 may include: between 1 and 30 of the plurality of the first dividers 332 and between 1 and 30 of the second dividers 334, between 2 and 20 of the plurality of the first dividers 332 and between 2 and 20 of the second dividers 334, between 3 and 15 of the plurality of the first dividers 332 and between 3 and 15 of the second dividers 334, between 4 and 10 of the plurality of the first dividers 332 and between 4 and 10 of the second dividers 334, or any other suitable number of dividers.

[0102] The first and second dividers 332, 334 cooperate with each other to define chambers 335 configured to receive drug delivery devices 60. For example, the first and second dividers 332, 334 of the partition 314, as shown in Fig. 20, define forty-five (45) chambers 335, but any other suitable number of chambers 335 may be utilized. For example, the partition 314 may define between about 20 and 150 chambers 335, between about 50 and 120 chambers 335, between about 80 and 100 chambers 335, or any other suitable number of chambers 335.

[0103] As shown in Fig. 24, each chamber 335 may be configured to receive approximately five (5) drug delivery devices 60 such that each tray 310 is configured to receive up to 225 drug delivery devices 60. However, any other suitable number of drug delivery devices 60 may be utilized. For example, each chamber 335 may be configured to receive approximately 2 to 20 drug delivery devices 60, 3 to 15 drug delivery devices 60, 4 to 10 drug delivery devices 60, 5 to 8 drug delivery devices, or any other suitable number of drug delivery devices 60. In some embodiments, each tray 310 may be configured to receive at least 200 drug delivery devices 60, at least 225 drug delivery devices 60, at least 320 drug delivery devices 60, at least 480 drug delivery devices 60, at least 495 drug delivery devices, at least 520 drug delivery devices 60, or any other suitable number of drug delivery devices 60.

[0104] As shown in Fig. 24, each chamber 335 may be configured to receive approximately five (5) drug delivery devices 60, although any other suitable number of drug delivery devices 60 may be utilized. Each of the drug delivery devices 60 shown in Fig. 24 includes a pre-filled syringe 50 positioned within a blister pack 61 (Figs. 3-4). The blister pack 61 generally includes a tray 62 and a cover 68 configured to seal the tray 62. The blister pack tray 62 may be coupled with the cover 68. As a more specific example, the blister pack tray 62 may be sealed with the cover 68 after the pre-filled syringe 50 is filled and assembled. The blister pack tray 62 may be made of any suitable material, such as Polyethylene Terephthalate Glycol Copolymer (PETG) and the cover 68 may be made of any suitable material, such as Tyvek or any suitable medical paper. The cover 68 is made of a material that is gas porous to permit and / or facilitate, during the external sterilization process, entry (and exit) of the sterilization gas (e.g., nitrogen dioxide) into and out of the internal chamber defined by the blister pack tray 62 and the cover 68. As a more specific example, the cover 68 includes micropores such that the cover 68 may be gas permeable to facilitate external sterilization of the pre-filled syringe 50 while it is in the blister pack 60. As an even more specific example, the blister pack tray 62 may not be gas permeable, such that the sterilization gas may travel through the cover 68 but not through the blister pack tray 62.11105-W001-SEC

[0105] As mentioned above, the drug delivery devices 60 each include a pre-filled syringe 50 positioned within a blister pack 61 (e.g., the tray 62 which has been sealed with the cover 68) so that the drug delivery devices 60 are ready for the step of external sterilization. As shown in Figs. 24 and 25, the drug delivery devices 60 are positioned vertically in a front-to-back configuration in the chamber 335. In other words, the drug delivery devices 60 are positioned vertically with respect to each other such that the cover 68 of one device 60 abuts and / or is adjacent to the blister pack tray 62 of an adjacent device. This front-to-back configuration helps facilitate entry and exit of the sterilization gas into the internal chamber, defined by the blister pack tray 62 and the cover 68, of each drug delivery device 60. As a more specific example, if adjacent devices 60 were arranged such that the respective covers 68 would abut each other, the respective covers could potentially block or prevent entry of sterilization gas into the internal chamber defined by the blister pack tray 62 and the cover 68. However, because adjacent devices 60 are arranged such that the cover 68 of one device 60 abuts and / or is adjacent to the blister pack tray 62 of an adjacent device 60, the sterilization gas can enter the internal chamber of each drug delivery device 60.

[0106] The dividers 332, 334 shown in Fig. 19-25 include a plurality of metal bars or rods. Each of the metal bars or rods may include, but is not limited to, round stock, rod stock, or wire. For example, the plurality of first dividers 332 includes a first set of metal bars or rods extending in the first direction, and the plurality of second dividers 334 includes a second set of metal bars or rods extending in the second direction substantially perpendicular to the first direction. The plurality of metal bars or rods that define the first dividers 332 in the tray 210 and the plurality of metal bars or rods that define the second dividers 334 are spaced out from each other such that there is an opening between any two of the metal bars or rods. These openings optimize flow of the sterilization gas and help facilitate distribution of the sterilization gas through the plurality of chambers 335 within the tray 310, while also providing a desired amount of structural stability for the tray 310 and / or the drug delivery devices 60 located therein. In some embodiments, the tray 310 may be reusable between different sterilization processes. In other embodiments, the tray 310 may be disposable such that the tray 310 can only be used for a single sterilization process, a two cycle (2X) sterilization process, or a different number of sterilization processes. In some embodiments, as shown in Fig. 21, the bottom tray 312 may be made of a wire mesh to optimize flow of the sterilization gas through the openings within the wire mesh and help facilitate distribution of the sterilization gas through the plurality of chambers 335 within the tray 310. Moreover, when a plurality of the trays 310 are loaded onto a rack, as discussed in more detail below, the wire mesh will optimize flow of the sterilization gas from one tray 310 to another tray 310 within the rack and help facilitate distribution of the sterilization gas within a sterilization chamber. In some embodiments, the bottom tray 312 may be made of interwoven metal bars or rods. In other embodiments, the bottom tray 312 may be made of parallel wires to provide lateral retention of the drug delivery devices 60 within the tray 312 such that the drug delivery devices 60 do not slide down when loading the tray 312 onto a rack.

[0107] Referring now to Figs. 26-28, an exemplary rack 320 for supporting a plurality of the trays 310 is shown. The rack 320 is generally rectangular parallelepiped shaped having a front side 321, a rear side 324, a left side 322, and a right side 323. The rack 320 includes a metal frame 326 positioned on top of a base 327. As shown in Figs. 26-28, a plurality of metal rods may be coupled with each other to form the metal frame 326. The base 327 may include a plurality of base frames 327a, 327b, 327c configured to support the metal frame 326. The plurality of base frames 327a, 327b, 327c may be coupled to the metal frame 326, for example, via welding or bolting. The rack 320, including the metal frame 326 and / or the base 327, may be made of any rigid material that has a low affinity for nitrogen dioxide adsorption and retention. For example, the rack 320 may be made of stainless steel (e.g., austenitic (300-series) stainless steel), titanium, aluminum, silver, gold, or nitinol. Accordingly, the rack 320 may not absorb and retain any sterilant gas when loaded into a sterilization chamber for external sterilization of drug delivery devices supported therein. Moreover, because the rack 320 is made of stainless steel (e.g., austenitic (300-series) stainless steel), titanium, aluminum, silver, gold, or nitinol, the rack 320 may prevent or offer more resistance to damages during an external sterilization process.11105-W001-SEC

[0108] As shown in Figs. 26-28, the rack 320 may further include a plurality of rails 325 extending from the front side 321 of the rack 320 to the rear side 324 of the rack 320. The rails 325 may be fixed (e.g., bolted) to the metal frame 326 and configured to hold and support a plurality of the trays 310 within the rack 320. For example, each of the trays 310 may be slidably received within a pair of rails 325 so that the trays 310 can be loaded into individual locations within the rack 320. As shown in Figs. 26-28, each rack 320 may have at least 28 pairs of rails 325 such that at least 28 trays can be loaded onto each rack 320. Because each tray 310 shown in Figs. 19-25 is configured to receive up to 225 drug delivery devices 60 therein, the rack 320 shown in Figs. 26-28 may be configured to hold up to 6300 drug delivery devices 60 when trays 310 are loaded onto each pair of rails 325 within the rack 320. In some embodiments, the rack 320 may have at least 30 pairs of rails 325 such that the rack 320 can support at least 30 trays 310 therein, the rack 320 may have at least 32 pairs of rails 325 such that the rack 320 can support at least 32 trays 310 therein, or any suitable number of rails 325 may be utilized.

[0109] As shown in Figs. 26-28, the plurality of base frames 327a, 327b, 327c that define the base 327 of the rack 320 may each have an opening configured to receive at least a portion of a forklift, or any other machine used to lift and move materials over short distances. Accordingly, once the trays 310 are inserted within the rack 320, the rack 320 can be lifted and moved into a sterilization chamber before an external sterilization process begins, and lifted and moved out of the sterilization chamber after the external sterilization process is complete. This reduces or eliminates the need to individually handle each tray 310, such as manually loading and unloading each tray 310 into and out of the sterilization chamber, thereby optimizing operability, efficiency, and ergonomics. For example, conventional methods of loading drug delivery devices in a sterilization chamber for external sterilization may include manually assembling a plastic tote, keeping the plastic tote stabilized while loading each drug delivery device into the plastic tote, and manually loading individual plastic totes into the sterilization chamber. However, the trays 310 of the present disclosure may be efficiently loaded onto the rack 320, and the rack 320 may be loaded into the sterilization chamber, thereby reducing the need to individually load each tray 310. Moreover, by reducing or eliminating manual handling of each tray 310, the tray 310, as well as the drug delivery devices 60 held therein and the drug product filled within each drug delivery device 60, are less prone to damage and droppage. Moreover, the dimensions of the base 327 and the height of the rack 320 may be optimized to increase load capacity within the usable volume of a sterilization chamber without wasting any space.

[0110] In some embodiments, the rack 320 may include designated locations on an external surface thereof to hold or support one or more process challenge devices (PCDs). For example, the rack 320 may include one or more slots on the metal frame 326 to hold or support PCDs. In other embodiments, one or more PCDs may be attached to the metal frame 326 of the rack 320. In some embodiments, each tray 310 may comprise a removable cover configured to protect the drug delivery devices 60 from exposure to light before and / or after a sterilization process. The removable cover may have one or more flaps with hook and loop closure that can be used to removably secure the cover on top of the tray 310. In some embodiments, the removal cover may be configured to protect the entire rack 320 after each tray 310 has been fully assembled and loaded onto the rack 320. The removable cover may have one or more flaps with hook and loop closure that can be used to removably secure the cover on the entire rack 320. In some embodiments, the one or more flaps may be removed to allow for individual or multiple sets of trays 310 to be loaded and unloaded from the rack 320 while ensuring light protection for the remaining loaded trays 310 in the rack 320. In some embodiments, the removable cover may have a slot configured to receive a label and / or a placard. The slot may be used to display the label and / or the placard. The slot may be placed at the base and may further include a flap such that the label and / or the placard to be displayed is at a designated location on the rack 320 and the opening on the cover is to check the label of that particular load.

[0111] As will be recognized, the devices 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 in11105-W001-SEC accordance with the features of the present disclosure included in that embodiment. Other advantages not specifically listed herein may also be recognized as well.

[0112] 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.

[0113] The drug will be contained in a reservoir. In some instances, the reservoir is a pre-filled syringe. The pre-filled syringe may have a maximum fill volume, i.e., a volume which can be maximally taken up by the syringe, of 0.3 ml to 1 ,5ml, preferably of 0.5 ml to 1.0 ml. The volume of the liquid composition filled into the syringe may be about 0.05 ml to 1.0 ml; about 0.1 ml to 0.5 ml; about 0.14 ml to 0.3 ml; or about 0.15 ml to 0.2 ml. Syringes are typically filled with a larger volume than the volume actually administered to the patient to take into account any dead space within the syringe and the needle and the loss due to the preparation of the syringe for injection. Therefore, the volume which is actually administered to the patient may be between 0.01 ml and 1 ml; between 0.02 and 0.5 ml; between 0.025 and 0.5 ml; between 0.03 ml and 0.05 ml; or 0.05 ml.

[0114] In some embodiments, the reservoir of the pre-filled syringe includes a VEGF antagonist. The term "VEGF antagonist" refers to a molecule which specifically interacts with VEGF and inhibits one or more of its biological activities, e.g., its mitogenic, angiogenic and / or vascular permeability activity. It is intended to include both anti-VEGF antibodies and antigenbinding fragments thereof and non-antibody VEGF antagonists. Non-antibody VEGF antagonists include aflibercept, pegaptanib and antibody mimetics. Preferably, the non-antibody VEGF antagonist is aflibercept. Aflibercept which is presently marketed under the name Eylea® and which is also known as VEGF-trap is a recombinant human soluble VEGF receptor fusion protein in which portions of human VEGF receptors 1 and 2 extracellular domains are fused to the Fc portion of human IgGI (Holash et al. (2002) Proc. Natl. Acad. Sci. USA 99(17): 11393-11398; WO 00 / 75319 Al).

[0115] 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).

[0116] In other embodiments, the drug delivery device may contain or be used with an erythropoiesis stimulating agent (ESA), which may be in liquid or lyophilized form. An ESA is any molecule that stimulates erythropoiesis. In some embodiments, an ESA is an erythropoiesis stimulating protein. As used herein, “erythropoiesis stimulating protein” means any protein that directly or indirectly causes activation of the erythropoietin receptor, for example, by binding to and causing dimerization of the receptor. Erythropoiesis stimulating proteins include erythropoietin and variants, analogs, or derivatives thereof that bind to and activate erythropoietin receptor; antibodies that bind to erythropoietin receptor and activate the receptor; or peptides that bind to and activate erythropoietin receptor. Erythropoiesis stimulating proteins include, but are not limited to, Epogen® (epoetin alfa), Aranesp® (darbepoetin alfa), Dynepo® (epoetin delta), Mircera® (methyoxy polyethylene glycol-epoetin beta), Hematide®, MRK-2578, INS-22, Retacrit® (epoetin zeta), Neorecormon® (epoetin beta), Silapo® (epoetin zeta), Binocrit® (epoetin alfa), epoetin alfa Hexal, Abseamed® (epoetin alfa), Ratioepo® (epoetin theta), Eporatio® (epoetin theta), Biopoin® (epoetin theta), epoetin alfa, epoetin beta, epoetin iota, epoetin omega, epoetin delta, epoetin zeta, epoetin11105-W001-SEC theta, and epoetin delta, pegylated erythropoietin, carbamylated erythropoietin, as well as the molecules or variants or analogs thereof.

[0117] 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 hLL2 gamma-chain disulfide linked to a human-mouse monoclonal hLL2 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-I GF- 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 lgG2 antibodies, including but not limited to fully human lgG2 monoclonal antibody that binds an epitope in the first immunoglobulin-like domain of B7RP-1, including but not limited to those that inhibit the interaction of B7RP-1 with its natural receptor, ICOS, on activated T cells; IL-15 specific antibodies, peptibodies, related proteins, and the like, such as, in particular, humanized monoclonal antibodies, including but not limited to HuMax IL-15 antibodies and related proteins, such as, for instance, 145c7; IFN gamma specific antibodies, peptibodies, related proteins and the like, including but not limited to human IFN gamma specific antibodies, and including but not limited to fully human anti-IFN gamma antibodies; TALL-1 specific antibodies, peptibodies, related proteins, and the like, and other TALL specific binding proteins; Parathyroid hormone (“PTH”) specific antibodies, peptibodies, related proteins, and the like; Thrombopoietin receptor (“TPO-R”) specific antibodies, peptibodies, related proteins, and the like;Hepatocyte growth factor (“HGF”) specific antibodies, peptibodies, related proteins, and the like, including those that target the HGF / SF:cMet axis (HGF / SF:c-Met), such as fully human monoclonal antibodies that neutralize hepatocyte growth factor / scatter (HGF / SF); TRAIL-R2 specific antibodies, peptibodies, related proteins and the like; Activin A specific antibodies, peptibodies, proteins, and the like; TGF-beta specific antibodies, peptibodies, related proteins, and the like; Amyloid-beta protein specific antibodies, peptibodies, related proteins, and the like; c-Kit specific antibodies, peptibodies, related proteins, and the like, including but not limited to proteins that bind c-Kit and / or other stem cell factor receptors; OX40L specific antibodies, peptibodies, related proteins, and the like, including but not limited to proteins that bind OX40L and / or other ligands of the 0X40 receptor; Activase® (alteplase, tPA); Aranesp® (darbepoetin alfa) Erythropoietin [30-asparagine, 32-threonine, 87-valine, 88-asparagine, 90-threonine], Darbepoetin alfa, novel erythropoiesis stimulating protein (NESP); Epogen® (epoetin alfa, or erythropoietin); GLP-1, Avonex® (interferon beta-1a); Bexxar® (tositumomab, anti-CD22 monoclonal antibody); Betaseron® (interferon-beta); Campath® (alemtuzumab, anti-CD52 monoclonal antibody); Dynepo® (epoetin delta); Velcade® (bortezomib); MLN0002 (anti- a4B7 mAb); MLN 1202 (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 Monoclonal11105-W001-SEC 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® (17-1A, edrecolomab); Trabio® (lerdelimumab); TheraCim hR3 (nimotuzumab); Omnitarg (pertuzumab, 2C4); Osidem® (IDM-1); OvaRex® (B43.13); Nuvion® (visilizumab); cantuzumab mertansine (huC242-DM1); NeoRecormon® (epoetin beta); Neumega® (oprelvekin, human interleukin-11); Orthoclone OKT3® (muromonab-CD3, anti-CD3 monoclonal antibody); Procrit® (epoetin alfa); Remicade® (infliximab, anti-TNFa monoclonal antibody); Reopro® (abciximab, anti-GP llb / llia receptor monoclonal antibody); Actemra® (anti-IL6 Receptor mAb); Avastin® (bevacizumab), HuMax-CD4 (zanolimumab); Mvasi™ (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 lgG1 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 lgG1 Fc); Zenapax® (daclizumab); Zenapax® (daclizumab, anti-IL-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|31 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; anti-ganglioside GM2 mAb; anti-GDF-8 human mAb (MYO-029); anti-GM-CSF Receptor mAb (CAM-3001); anti-HepC mAb (HuMax HepC); anti-IFNa mAb (MEDI-545, MDX-198); anti-IGF1R mAb; anti-IGF-1 R mAb (HuMax-Inflam); anti-IL12 mAb (ABT-874); anti-IL12 / IL23 mAb (CNTO 1275); anti-IL13 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).

[0118] In some embodiments, the drug delivery device may contain or be used with a sderostin antibody, such as but not limited to romosozumab, blosozumab, BPS 804 (Novartis), Evenity® (romosozumab-aqqg), another product containing romosozumab for treatment of postmenopausal osteoporosis and / or fracture healing and in other embodiments, a monoclonal antibody (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; OrienXOlO; G207, 1716; NV1020; NV12023; NV1034; and NV1042. In some embodiments, the drug delivery device may contain or be used with endogenous tissue inhibitors of11105-W001-SEC 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. In some embodiments, the drug delivery device may contain or be used with Bemarituzumab, a monoclonal antibody that inhibits fibroblast growth factor receptor 2b (FGFR2b) for the treatment of advanced Gastric and Gastroesophageal Junction (GEJ) cancers. Additionally, 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 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 Avsola™ (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-[(1S)-1-(3-ethoxy-4-methoxyphenyl)-2-(methylsulfonyl)ethyl]-2, 3-di hydro- 1 ,3-dioxo- 1 H-isoi ndol-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 ParsabivT® (etelcalcetide HOI, KAI-4169) or another product containing etelcalcetide HOI 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 206 (nivolumab), a biosimilar candidate to OPDIVO®, or another product containing a monoclonal antibody that targets the PD-1 protein on T cells. In some embodiments, the drug delivery device may contain or be used with ABP 234 (pembrolizumab), a biosimilar candidate to KEYTRUDA®, or another product containing a monoclonal antibody that binds to the PD-1 protein on immune cells. In some embodiments, the drug delivery device may contain or be used with ABP 692 (ocrelizumab), a biosimilar candidate to OCREVUS®, or another product containing a humanized anti-CD20 monoclonal antibody. In some embodiments, the drug delivery device may contain or be used with daxdilimab, a human monoclonal antibody against ILT7 or another product. 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 Pavblu®, 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 lgG1). 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 05. 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 I mdelltra® (tarlatamab-dlle), an anti-delta-like ligand 3 (DLL3) x anti-CD3 bispecific T cell engager (BiTE) molecule, or another product containing tarlatamab-dlle for the treatment of small cell lung cancer. 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 Lumakras® (sotorasib), a KRASG12Csmall molecule inhibitor, or another product containing11105-W001-SEC a KRASG12Csmall molecule inhibitor. In some embodiments, the drug delivery device may contain or be used with Tezaspire® (tezepelumab-ekko), a human monoclonal antibody that inhibits the action of thymic stromal lymphopoietin (TSLP), or another product containing a human monoclonal antibody that inhibits the action of TSLP. In some embodiments, the drug delivery device may contain or be used with Tavneos® (avacopan), a complement 5a receptor 1 (C5aR1) antagonist that inhibits the effects of C5a. In some embodiments, the drug delivery device can contain or be used with Tepezza® (teprotumumab-trbw), a human monoclonal antibody against insulin-like growth factor-1 receptor (I GF- 1 R), or another product containing a human monoclonal antibody against I GF- 1 R. In some embodiments, the drug delivery device can contain or be used with Uplizna® (inebilizumab-cdon), a humanized monoclonal antibody that binds to the B cell-specific surface antigen CD19, or another product containing a humanized monoclonal antibody that binds to the B cell-specific surface antigen CD19. In some embodiments, the drug delivery device may contain or be used with rocatinlimab (AMG 451), a human anti-OX40 monoclonal antibody that is expressed on activated T cells and blocks 0X40 to inhibit and / or reduce the number of 0X40 pathogenic T cells that are responsible for driving system and local atopic dermatitis inflammatory responses. In some embodiments, the drug delivery device may contain or be used with ordesekimab (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 olpasiran (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 Wezlana® / Wezenla™ (human lgG1 kappa antibody), a biosimilar candidate to Stelara®, or another product that contains human lgG1 kappa antibody and / or binds to the p40 subunit of 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 lgG1), a biosimilar candidate to Humira®, or another product that contains human mab anti-TNF human IgG 1. In some embodiments, the drug delivery device may contain or be used with AMG 104, or another product containing a human anti-TSLP Fab. In some embodiments, the drug delivery device may contain or be used with AMG 193, or another product containing a small molecule methylthioadenosine (MTA) cooperative protein arginine methyltransferase 5 (PRMT5) inhibitor. In some embodiments, the drug delivery device may contain or be used with AMG 329, or another product containing a human monoclonal antibody that binds and neutralizes the function of the FLT3-ligand. In some embodiments, the drug delivery device may contain or be used with AMG 732, or another product containing a monoclonal antibody against insulin-like growth factor-1 receptor (IGF- 1 R). In some embodiments, the drug delivery device may contain or be used with AMG 305, or another product containing dual-targeting bispecific T cell engager (BiTE) molecule against P-cadherin (CDH3), mesothelin (MSLN) and CD3. In some embodiments, the drug delivery device may contain or be used with AMG 355, or another product containing an anti-CCR8 monoclonal antibody. In some embodiments, the drug delivery device may contain or be used with AMG 378, or another product containing a small molecule for the treatment of ulcerative colitis. In some embodiments, the drug delivery device may contain or be used with AMG 410, or another product containing a small molecule for the treatment of solid tumors. In some embodiments, the drug delivery device may contain or be used with AMG 513, or another product containing a molecule for the treatment of obesity. In some embodiments, the drug delivery device may contain or be used with AMG 691, or another product containing a monoclonal antibody for the treatment of asthma. 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 MariTide™ (AMG 133), or another product containing a gastric inhibitory polypeptide receptor (GIPR)11105-W001-SEC antagonist and GLP-1R agonist. In some embodiments, the drug delivery device may contain or be used with AMG 171 or another product containing a Growth Differential Factor 15 (GDF15) analog. In some embodiments, the drug delivery device may contain or be used with AMG 176 or another product containing a small molecule inhibitor of myeloid cell leukemia 1 (MCL-1). In some embodiments, the drug delivery device may contain or be used with AMG 199 or another product containing a half-life extended (HLE) bispecific T cell engager construct (BITE®). In some embodiments, the drug delivery device may contain or be used with AMG 256 or another product containing an anti-PD-1 x IL21 mutein and / or an IL-21 receptor agonist designed to selectively turn on the Interleukin 21 (IL-21) pathway in programmed cell death-1 (PD-1) positive cells. In some embodiments, the drug delivery device may contain or be used with AMG 330 or another product containing an anti-CD33 x anti-CD3 BiTE® (bispecific T cell engager) construct. In some embodiments, the drug delivery device may contain or be used with AMG 404 or another product containing a human anti-programmed cell death-1 (PD-1) monoclonal antibody being investigated as a treatment for patients with solid tumors. In some embodiments, the drug delivery device may contain or be used with AMG 427 or another product containing a half-life extended (HLE) anti-fms-like tyrosine kinase 3 (FLT3) x anti-CD3 BiTE® (bispecific T cell engager) construct. In some embodiments, the drug delivery device may contain or be used with AMG 430 or another product containing an anti- Jagged- 1 monoclonal antibody. In some embodiments, the drug delivery device may contain or be used with AMG 506 or another product containing a multi-specific FAP x 4-1 BB-targeting DARPin® biologic under investigation as a treatment for solid tumors. In some embodiments, the drug delivery device may contain or be used with AMG 509 (xaluritamig) 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 vlll (EGFRvlll) BiTE® (bispecific T cell engager) molecule. In some embodiments, the drug delivery device may contain or be used with AMG 673 or another product containing a half-life extended (HLE) anti-CD33 x anti-CD3 BiTE® (bispecific T cell engager) construct. In some embodiments, the drug delivery device may contain or be used with AMG 701 or another product containing a half-life extended (HLE) anti-B-cell maturation antigen (BCMA) x anti-CD3 BiTE® (bispecific T cell engager) construct. In some embodiments, the drug delivery device may contain or be used with AMG 757 or another product containing a half-life extended (HLE) anti- delta-like ligand 3 (DLL3) x anti-CD3 BiTE® (bispecific T cell engager) construct. In some embodiments, the drug delivery device may contain or be used with AMG 910 or another product containing a half-life extended (HLE) epithelial cell tight junction protein claudin 18.2 x CD3 BiTE® (bispecific T cell engager) construct. In some embodiments, the drug delivery device may contain or be used with Dazodalibep, a fusion protein binding CD40L on T cells to block their interaction with CD40-expressing B cells.

[0119] 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.

[0120] 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

11105-W001-SEC What is claimed is:

1. A system for use during an external sterilization process of a plurality of drug delivery devices, the system comprising:a tray including at least one partition at least partially enclosed by the tray, the at least one partition defining a plurality of chambers, wherein each of the plurality of chambers is configured to receive a plurality of drug delivery devices in a front-to-back configuration; anda rack including a metal frame and a plurality of rails fixed to the metal frame, wherein the plurality of rails are configured to support the tray within the rack.

2. The system of claim 1 , wherein the at least one partition includes a plurality of first dividers extending in a first direction and a plurality of second dividers extending in a second direction generally perpendicular to the first direction.

3. The system of claim 2, wherein each of the plurality of first dividers includes a first set of metal bars or metal rods extending in the first direction, and each of the plurality of second dividers includes a second set of metal bars or metal rods extending in the second direction generally perpendicular to the first direction.

4. The system of claim 1 , wherein the at least one partition includes a plurality of openings to permit and / or facilitate distribution of a sterilization gas through the plurality of chambers.

5. The system of claim 4, wherein the sterilization gas includes nitrogen dioxide.

6. The system of claim 1 , wherein the tray and the at least one partition are made of stainless steel, titanium, aluminum, silver, gold, or nitinol.

7. The system of claim 6, wherein the rack is made of stainless steel.

8. The system of claim 1 , wherein the plurality of drug delivery devices each include a pre-filled syringe positioned within a blister pack.

9. The system of claim 8, wherein the pre-filled syringe includes a syringe barrel, a plunger rod, a stopper, and a backstop.

10. The system of claim 8, wherein the blister pack includes a tray and a cover configured to seal the tray.

11. The system of claim 10, wherein the cover is made of a porous material to permit and / or facilitate entry of a sterilization gas through the cover and into the tray of the blister pack.

12. The system of claim 11 , wherein the tray is gas impermeable to prevent travel of the sterilization gas through the tray.11105-W001-SEC 13. The system of claim 11, wherein each of the plurality of chambers is configured to receive the plurality of drug delivery devices in the front-to-back configuration such that the cover of one of the plurality of drug delivery devices abuts the tray of an adjacent one of the plurality of drug delivery devices.

14. The system of claim 1, wherein each of the plurality of chambers is configured to receive at least three drug delivery devices.

15. The system of claim 14, wherein each of the plurality of chambers is configured to receive at least four drug delivery devices.

16. The system of claim 15, wherein each of the plurality of chambers is configured to receive at least five drug delivery devices.

17. The system of claim 1, wherein the tray is configured to receive at least 225 drug delivery devices.

18. The system of claim 17, wherein the tray is configured to receive at least 320 drug delivery devices.

19. The system of claim 18, wherein the tray is configured to receive at least 480 drug delivery devices.

20. The system of claim 1, wherein the rack is configured to support at least 16 trays.

21. The system of claim 20, wherein the rack is configured to support at least 20 trays.

22. The system of claim 21 , wherein the rack is configured to support at least 28 trays.

23. The system of claim 1 , wherein the rack includes a base defining a bottom side thereof, and wherein the base includes a plurality of slots configured to receive at least a portion of a forklift.

24. The system of claim 1, wherein the tray is disposable.

25. A system for use during an external sterilization process of a plurality of drug delivery devices, the system comprising:a container including an outer housing and at least one partition at least partially enclosed by the outer housing, the at least one partition defining a plurality of chambers, wherein each of the plurality of chambers is configured to receive a plurality of drug delivery devices in a front-to-back configuration; anda rack including a metal frame and a plurality of rails fixed to the metal frame, wherein the plurality of rails are configured to support the container within the rack.

26. The system of claim 25, wherein the at least one partition includes a plurality of first dividers extending in a first direction and a plurality of second dividers extending in a second direction generally perpendicular to the first direction.11105-W001-SEC 27. The system of claim 26, wherein the plurality of first dividers includes a first set of wire mesh sheets, perforated metal sheets, or expanded metal sheets extending in the first direction, and wherein the plurality of second dividers includes a second set of wire mesh sheets, perforated metal sheets, or expanded metal sheets extending in the second direction generally perpendicular to the first direction.

28. The system of claim 27, wherein the at least one partition includes a plurality of openings to permit and / or facilitate distribution of a sterilization gas through the plurality of chambers.

29. The system of claim 28, wherein the sterilization gas includes nitrogen dioxide.

30. The system of claim 25, wherein the outer housing and the at least one partition are made of stainless steel, titanium, aluminum, silver, gold, or nitinol.

31. The system of claim 30, wherein the rack is made of stainless steel.

32. The system of claim 25, wherein the outer housing is made of one or more wire mesh sheets, perforated metal sheets, or expanded metal sheets, and wherein the outer housing includes a plurality of openings to permit and / or facilitate entry of a sterilization gas into an inner volume of the outer housing.

33. The system of claim 25, wherein the plurality of drug delivery devices each include a pre-filled syringe positioned within a blister pack.

34. The system of claim 33, wherein the pre-filled syringe includes a syringe barrel, a plunger rod, a stopper, and a backstop.

35. The system of claim 33, wherein the blister pack includes a tray and a cover configured to seal the tray.

36. The system of claim 35, wherein the cover is made of a porous material to permit and / or facilitate entry of a sterilization gas through the cover and into the tray of the blister pack.

37. The system of claim 36, wherein the tray is gas impermeable to prevent travel of the sterilization gas through the tray.

38. The system of claim 36, wherein each of the plurality of chambers is configured to receive the plurality of drug delivery devices in the front-to-back configuration such that the cover of one of the plurality of drug delivery devices abuts the tray of an adjacent one of the plurality of drug delivery devices.

39. The system of claim 25, wherein each of the plurality of chambers is configured to receive at least three drug delivery devices.

40. The system of claim 25, wherein the container includes at least two partitions, wherein the at least two partitions include a first partition and a second partition stacked on top of the first partition, and wherein the first partition and the11105-W001-SEC second partition are separated by a removable divider made of a wire mesh sheet, a perforated metal sheet, or an expanded metal sheet.

41. The system of claim 25, wherein the rack is configured to support 16 containers.

42. The system of claim 25, wherein the container is disposable.

43. A system for use during an external sterilization process of a plurality of drug delivery devices, the system comprising:a first container including:a first outer housing including a plurality of openings to permit and / or facilitate entry of sterilization gas into an inner volume thereof; andat least one partition at least partially enclosed by the outer housing, the at least one partition defining a plurality of chambers, wherein each of the plurality of chambers is configured to receive a plurality of drug delivery devices in a front-to-back configuration;a second container including a second outer housing; andan interlocking mechanism disposed on the first outer housing and the second outer housing, wherein the interlocking mechanism is configured to removably couple the first container with the second container.

44. The system of claim 43, wherein the at least one partition includes a plurality of first dividers extending in a first direction and a plurality of second dividers extending in a second direction generally perpendicular to the first direction.

45. The system of claim 44, wherein the plurality of first dividers includes a first set of wire mesh sheets, perforated metal sheets, or expanded metal sheets extending in the first direction, and wherein the plurality of second dividers includes a second set of wire mesh sheets, perforated metal sheets, or expanded metal sheets extending in the second direction generally perpendicular to the first direction.

46. The system of claim 45, wherein the at least one partition includes a plurality of openings to permit and / or facilitate distribution of a sterilization gas through the plurality of chambers, and wherein the sterilization gas includes nitrogen dioxide.

47. The system of claim 43, wherein the first outer housing and the at least one partition are made of stainless steel, titanium, aluminum, silver, gold, or nitinol.

48. The system of claim 43, wherein the first outer housing and the second outer housing are each made of one or more wire mesh sheets, perforated metal sheets, or expanded metal sheets.

49. The system of claim 43, wherein the plurality of drug delivery devices each include a pre-filled syringe positioned within a blister pack.

50. The system of claim 49, wherein the pre-filled syringe includes a syringe barrel, a plunger rod, a stopper, and a backstop.11105-W001-SEC51. The system of claim 49, wherein the blister pack includes a tray and a cover configured to seal the tray.

52. The system of claim 51 , wherein the cover is made of a porous material to permit and / or facilitate entry of a sterilization gas through the cover and into the tray of the blister pack.

53. The system of claim 52, wherein the tray is gas impermeable to prevent travel of the sterilization gas through the tray.

54. The system of claim 52, wherein each of the plurality of chambers is configured to receive the plurality of drug delivery devices in the front-to-back configuration such that the cover of one of the plurality of drug delivery devices abuts the tray of an adjacent one of the plurality of drug delivery devices.

55. The system of claim 43, wherein the interlocking mechanism includes a protrusion disposed on one of the first outer housing and the second outer housing and a recess disposed on the other one of the first outer housing and the second outer housing, wherein the recess is configured to receive the protrusion via a snap-fit configuration to removably couple the first container with the second container.

56. The system of claim 43, wherein the first container and the second container are disposable.

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