Tray-based sterile packaging of pharmaceutical vials and vial closures

Abstract

The present invention provides small batch packaging for vial seals and vial stoppers. The package includes a vial tray having a plurality of separate, spaced vial receptacles for receiving respective vials. The package also includes a vial seal tray having a plurality of separate, spaced apart seal receptacles for receiving respective vial seals. The package further includes a stopper tray having a plurality of separate spaced stopper receptacles for receiving respective vial seals. The seal channel may extend through a plurality of individually spaced apart seal receptacles to form a gap to facilitate grasping each vial seal. Similarly, the stopper channel may extend through a plurality of individually spaced apart stopper receptacles to form a gap to facilitate grasping each vial stopper.

Description

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS

[0002] This application is a divisional application of the Chinese invention patent application with the application date of December 28, 2021, application number 202180094315.5, and title “Tray-based sterile packaging of pharmaceutical vials and vial closures”.

[0003] The above-mentioned Chinese invention patent application claims the benefit of U.S. Provisional Patent Application No. 63 / 131,151 filed on December 28, 2020, and the disclosure of the U.S. Provisional Patent Application is incorporated herein by reference. Technical Field

[0004] The present disclosure relates generally to trays for vials and vial closures, and more particularly to sterile trays for pharmaceutical vial stoppers and vial seals. Background Art

[0005] The research and production of novel biopharmaceuticals such as various gene therapies require a small amount of manual or semi-automatic filling container closure systems. During this process, the steps of filling drug containers (such as glass or polymer vials), closing vials with elastomeric stoppers, and capping vials with crimped aluminum seals are usually performed manually, and are used for small batches using compact workspaces (such as small biosafety cabinets or laboratory tables with covers). However, stoppers and seals for pharmaceutical vials are usually manufactured and shipped in large quantities as bulk packaging (such as in sterile bags). For example, cell and gene therapy manufacturers usually use pharmaceutical closures that are only available in larger quantities of bulk packaging, which are developed for large-scale filling and sorting processes with automatic filling machines. When performed in a small biosafety cabinet, this may cause the unpacking process of the closure bulk packaging to be complicated and difficult, and cause the aseptic transfer process of the closure to the corresponding vial to be complicated and difficult. Therefore, there is a huge risk of microbial and particle contamination of the assembled and filled pharmaceutical vials.

[0006] In addition, such bulk packaging requires the user to unpack a small portion of the vial closure components from the bulk packaging and then place them in a biosafety cabinet before use. This unpacking process usually causes the user to drop the closure components onto the laboratory table surface or refill the contents of the bulk packaging into a separate container (such as a glass dish) under aseptic conditions. Such processes are also cumbersome because they are difficult to handle larger bulk packaging forms in a compact laboratory or biosafety cabinet setting. In addition, extracting a separate closure component from the bulk packaging requires multiple steps, which often causes many closure components to be touched and moved. Therefore, this process causes a huge risk of destroying the expected sterility of the closure components.

[0007] Therefore, the goal is to allow users to easily access both vial seals and vial stoppers from corresponding small batch pallets when working in a tight workspace. Such an arrangement would be much easier than having to use conventional packaging methods for seals and stoppers, which are bulk-packed in bags that the user must first empty on the surface of the workspace and then unfold the individual closure members in order to pick out each closure member for placement on the vials. Such conventional procedures are particularly difficult to implement in the limited space of a biosafety cabinet or on a laboratory table. In addition, there is a significant risk of contamination when the user must reach into the bulk closure bag to grab one or more of the closure elements because there is a high risk of contaminating other components in the bag due to the compromise of sterility therein.

[0008] Although conventional pallets for storage and storage of medical or pharmaceutical preparations are typically used on a large scale, such pallets are typically delivered to pharmaceutical manufacturers or factories for further processing in a predetermined arrangement (such as when held or contained in a support structure). However, such conventional pallets are not well suited for use in a laboratory or biosafety cabinet setting. Therefore, there is a clear and fundamental need for new, small-volume presentation pallets and associated kits that provide sterile, ready-to-use closure components, wherein the pallets and kits are designed for easy handling and safe use during filling and finishing processes in compact environments (including laboratory tables or biosafety cabinets, such as those used for small batches of cell and gene therapy drugs). Further, there is a need for pallets and kits that are safer and easier to handle than conventional bulk packaging by allowing the user to touch one individual component stored in the pallet at a time. Summary of the Invention

[0009] The aforementioned needs are largely met by the disclosed packaging tray, which includes a vial seal tray comprising: a body having a top surface defining an array of receptacles, the receptacle array including a plurality of receptacle rows, each of the plurality of receptacle rows including a plurality of individually spaced receptacles configured to releasably secure a corresponding vial seal; a connecting web disposed on the top surface of the vial seal tray and interconnecting the plurality of individual receptacles, each receptacle defining a hollow cavity extending downwardly from the top surface of the vial seal tray and forming a closed lower end, the hollow cavity configured to receive a portion of the vial seal; a region projecting upwardly from a central portion of the closed lower end of each receptacle for supporting the vial seal; and a channel extending through the plurality of individually spaced receptacles disposed in each respective receptacle row, the channel forming gaps on opposite sides of each receptacle to facilitate gripping the vial seal retained in the corresponding receptacle.

[0010] According to another aspect of the present disclosure, the plurality of receptacle rows are arranged parallel to each other and laterally offset from each other such that positions of each receptacle in adjacent receptacle rows are correspondingly offset from each other.

[0011] According to another aspect of the present disclosure, each receptacle has a generally cylindrical shape.

[0012] According to another aspect of the present disclosure, a vial closure tray includes a base defining a flange that projects outwardly along a perimeter of the vial closure tray.

[0013] According to another aspect of the present disclosure, a tray wall extends along a perimeter of the vial closure tray between the top surface and the base.

[0014] According to another aspect of the present disclosure, the tray wall includes a recess configured to facilitate stacking with another vial closure tray.

[0015] According to another aspect of the present disclosure, the top surface of the vial closure tray includes a chamfered edge along its perimeter to facilitate stacking with another vial closure tray.

[0016] According to another aspect of the present disclosure, the region includes an end portion having a hemispherical shape.

[0017] According to another aspect of the present disclosure, a vial stopper tray includes: a main body having a top surface defining a receptacle array, the receptacle array including a plurality of receptacle rows, each of the plurality of receptacle rows including a plurality of individually separated receptacles configured to releasably secure corresponding vial stoppers; a connecting web disposed on the top surface of the vial stopper tray and interconnecting the plurality of individual receptacles, each receptacle defining a hollow chamber extending downwardly from the top surface of the vial stopper tray and forming a closed lower end, the hollow chamber being configured to receive a portion of the vial stopper; a region protruding upwardly from a central portion of the closed lower end of each receptacle for supporting the vial stopper; and a channel extending through the plurality of individually separated receptacles disposed in each corresponding receptacle row, the channel forming gaps on opposite sides of each receptacle to facilitate gripping the vial stopper retained in the corresponding receptacle.

[0018] According to another aspect of the present disclosure, each receptacle includes a bumper configured to releasably secure a portion of a corresponding vial stopper within the chamber.

[0019] According to another aspect of the present disclosure, a bumper extends radially inward from an inner wall of the receptacle, the bumper forming a constricted opening to the cavity.

[0020] According to another aspect of the present disclosure, the bumper is configured to snap-fit ​​engage a portion of the vial stopper.

[0021] According to another aspect of the present disclosure, the channel is further configured to permit steam to flow along the receptacle row for sterilizing each vial stopper disposed in the receptacle row.

[0022] According to another aspect of the present disclosure, a reinforcing rib may be provided on the top surface of the stopper tray and extend perpendicularly to the channel for increasing the rigidity of the top surface of the stopper tray.

[0023] According to another aspect of the present disclosure, each receptacle has a generally cylindrical shape.

[0024] According to another aspect of the present disclosure, the vial stopper tray includes a base defining a flange projecting outwardly along a perimeter of the vial stopper tray.

[0025] According to another aspect of the present disclosure, a tray wall extends along the perimeter of the vial stopper tray between the top surface and the base.

[0026] According to another aspect of the present disclosure, the tray wall includes a recess configured to facilitate stacking with another vial stopper tray.

[0027] According to another aspect of the present disclosure, the tray wall includes corrugations configured to provide increased stability to the stopper tray.

[0028] According to another aspect of the present disclosure, the vial stopper tray includes chamfered edges along its perimeter to facilitate stacking with another vial stopper tray.

[0029] According to another aspect of the present disclosure, the region includes an end portion having a hemispherical shape.

[0030] According to another aspect of the present disclosure, a stopper tray cover is configured to be removably attached to the body of the vial stopper tray.

[0031] According to another aspect of the present disclosure, the stopper tray cover is configured to attach to the body of the vial stopper tray by a snap-fit ​​engagement.

[0032] According to another aspect of the present disclosure, the stopper tray cover includes a cover base having a sidewall extending along a periphery of the cover base and a locking protrusion extending from a portion of the sidewall for matingly engaging a portion of the body of the vial stopper tray.

[0033] According to another aspect of the present disclosure, the stopper tray cover includes a cover flange protruding outwardly along the periphery of the stopper tray cover.

[0034] According to another aspect of the present disclosure, the stopper tray cover includes a bottom surface having a plurality of retaining areas protruding therefrom, wherein each retaining area is sized and shaped to fit within a corresponding receptacle of the vial stopper tray when the stopper tray cover is attached to the stopper tray.

[0035] According to another aspect of the present disclosure, the stopper tray cover includes a cover reinforcement rib protruding from a bottom surface of the cover base.

[0036] According to another aspect of the present disclosure, a kit includes a vial tray, the vial tray comprising: a tray base having a vial receptacle array, the vial receptacle array comprising a plurality of vial receptacle rows, each of the plurality of vial receptacle rows comprising a plurality of individually spaced-apart vial receptacles configured to receive top portions of corresponding vials; and a vial seal tray comprising: a seal tray body having a top surface defining a seal receptacle array, the seal receptacle array comprising a plurality of seal receptacle rows, each of the plurality of seal receptacle rows comprising a plurality of individually spaced-apart seal receptacles configured to receive corresponding vial seals; and a seal channel extending through each corresponding seal receptacle disposed in the tray. The plurality of individually separated seal receptacles in a row, the seal channel forming a gap on opposite sides of each seal receptacle to facilitate gripping and retaining the vial seal in the corresponding receptacle; and a vial stopper tray, the vial stopper tray comprising: a stopper tray body having a top surface defining a stopper receptacle array, the stopper receptacle array comprising a plurality of stopper receptacle rows, each of the plurality of stopper receptacle rows comprising a plurality of individually separated stopper receptacles configured to receive corresponding vial stoppers; and a stopper channel extending through the plurality of individually separated stopper receptacles provided in each corresponding stopper receptacle row, the stopper channel forming a gap on opposite sides of each stopper receptacle to facilitate gripping and retaining the vial stopper in the corresponding receptacle.

[0037] According to another aspect of the present disclosure, the vial tray further includes a vial tray cover including a plurality of recesses arranged to receive bottom portions of respective vials.

[0038] According to another aspect of the present disclosure, the outer perimeter of the vial tray cover is shaped and sized to fit within the open portion of the tray base for sealing each vial within the vial tray.

[0039] According to another aspect of the present disclosure, the vial tray cover is configured for snap-fit ​​engagement with the base of the vial tray.

[0040] According to another aspect of the present disclosure, the primary container is configured to receive the vial closure tray.

[0041] According to another aspect of the present disclosure, the primary container is a first sterile bag for providing a first sterile barrier.

[0042] According to another aspect of the present disclosure, a secondary container is configured to receive the vial closure tray and the primary container.

[0043] According to another aspect of the present disclosure, the secondary container is a second sterile bag.The secondary bag for the through-hole seal tray can be used as a second sterile barrier.

[0044] Thus, certain embodiments of the present disclosure have been outlined so that their detailed description herein may be better understood, and so that the present disclosure's contribution to the art may be better appreciated. Additional embodiments of the present disclosure will be described below and form the subject matter of the appended claims.

[0045] In this regard, before explaining at least one aspect of the packaging tray in detail, it should be understood that the application of the packaging tray is not limited to the details of construction and the arrangement of components set forth in the following description or illustrated in the accompanying drawings. The packaging tray can have aspects other than those described and can be practiced and carried out in various ways. BRIEF DESCRIPTION OF THE DRAWINGS

[0046] In order that the present disclosure may be readily understood, various aspects of the packaging tray are shown by way of example in the drawings wherein like parts are designated by like reference numerals throughout.

[0047] Figure 1 Shown is a top perspective view of a vial closure tray according to the present disclosure.

[0048] Figure 2 Shown Figure 1 Bottom perspective view of the vial seal tray.

[0049] Figure 3 Shown Figure 1 Top view of a tray with vial seals.

[0050] Figure 4 Shown along Figure 3 Cross-sectional view of the vial seal tray taken along line IV-IV.

[0051] Figure 5 Shown is a top perspective view of a vial closure tray according to another implementation of the present disclosure.

[0052] Figure 6 Shown Figure 5 Bottom perspective view of the vial seal tray.

[0053] Figure 7 Shown Figure 5 Top view of a tray with vial seals.

[0054] Figure 8 Shown along Figure 7 Cross-sectional view of the vial seal tray taken along line VIII-VIII.

[0055] Figure 9 Shown is a top perspective view of a vial stopper tray according to the present disclosure.

[0056] Figure 10 Shown Figure 9 Bottom perspective view of the vial stopper tray.

[0057] Figure 11 Shown Figure 9 view of tray with vials and stoppers.

[0058] Figure 12 Shown along Figure 11 Cross-sectional view of the vial stopper tray taken along line XII-XII.

[0059] Figure 13 A top perspective view of a vial stopper tray according to another embodiment of the present disclosure is shown.

[0060] Figure 14 Shown Figure 13 Bottom perspective view of the vial stopper tray.

[0061] Figure 15 Shown Figure 13 view of tray with vials and stoppers.

[0062] Figure 16 Shown along Figure 15 Cross-sectional view of the vial stopper tray taken along line XVI-XVI.

[0063] Figure 17 Shown is a top perspective view of a vial stopper tray and a stopper tray cover according to another embodiment of the present disclosure.

[0064] Figure 18 Shown Figure 17 view of tray with vials and stoppers.

[0065] Figure 19 Shown along Figure 18 Cross-sectional view of the vial stopper tray taken along line XIX-XIX.

[0066] Figure 20 Shown Figure 17 Bottom view of the vial stopper tray lid.

[0067] Figure 21 Shown Figure 17 Front view of the vial stopper tray lid.

[0068] Figure 22 Shown is a top perspective view of a vial tray assembly according to the present disclosure.

[0069] Figure 23 Shown Figure 22 view of tray with vials.

[0070] Figure 24 Shown Figure 22 Bottom perspective view of the vial tray.

[0071] Figure 25 Shown is a bottom view of a vial tray cover according to the present disclosure.

[0072] Figure 26 Shown is a top perspective view of a vial tray assembly according to another implementation of the present disclosure.

[0073] Figure 27 Shown Figure 26 view of tray with vials.

[0074] Figure 28 Shown Figure 26 Bottom perspective view of the vial tray.

[0075] Figure 29 Shown Figure 26 Bottom perspective view of the vial tray lid.

[0076] Figure 30 Shown Figure 26 Bottom view of the vial tray lid. DETAILED DESCRIPTION

[0077] This disclosure describes various configurations of sterile trays for closures, such as stoppers and seals, for use with pharmaceutical vials. Figures 1 to 4A vial seal tray 100 is shown, comprising a receptacle array 110 having a plurality of individual receptacles 120, each of which is configured to releasably receive and secure a vial seal. The vial seal tray 100 can be disposed within a container to protect the vial seals, such as from contamination that could render each vial seal contained within the vial seal tray 100 unsuitable for subsequent assembly with a medication vial. The container can be made of a material suitable for sterilization. In some cases, the container can include one or more sterile bags sized and shaped to accommodate the vial seal tray, wherein the bag is heat-sealed once the tray is contained within the bag. For example, the vial seal tray 100 can be contained within a primary heat-sealed bag having a partial vacuum applied thereto to remove excess air. According to another aspect, the vial seal tray 100 within the primary bag can be further contained within a secondary heat-sealed bag.

[0078] The vial seal tray 100 includes a box-shaped body having a top surface 112 having a substantially rectangular shape and a base 114 defining a stabilizing flange that protrudes outwardly along the perimeter of the seal tray. Tray walls 116 extend along the perimeter of the seal tray between the top surface 112 and the base 114. The top surface 112 of the seal tray may include a chamfered edge 113 along its perimeter to facilitate stacking with another vial seal tray. The tray walls 116 may include one or more cutouts or notches 115 to similarly facilitate stacking with another vial seal tray. Furthermore, each corner 117 of the vial seal tray 100 may be cut away to facilitate inserting the tray into a primary bag during the packaging process. Furthermore, the corners 117 may also help facilitate stacking and reduce the amount of raw materials required to manufacture the tray and the associated costs.

[0079] Receptacle array 110 includes a plurality of spaced, linear receptacle rows 130. Receptacle rows 130 are interconnected by connecting webs 140 disposed on top surface 112 of vial seal tray 100. Each receptacle row 130 includes a plurality of individually isolated receptacles 120. Further, each receptacle row 130 defines a shallow channel 132 connecting each of the plurality of individually isolated receptacles 120. Shallow channel 132 defines a clearance space that allows access by tweezers or a user's fingers to facilitate removal of vial seals from the tray, as will be discussed further below. Further, some embodiments may include corrugations in the tray walls to increase the rigidity of the tray.

[0080] Each receptacle 120 is configured to receive a portion of a vial closure and may be substantially cylindrical in shape. A plurality of linear receptacle rows 130 are arranged in parallel and laterally offset from one another, such that corresponding receptacles 120 in adjacent receptacle rows are similarly offset from one another. This arrangement reduces the overall footprint of the pallet by minimizing the number of connecting webs 140 disposed between receptacle rows 130, thereby conserving space on the top surface 112 of the vial closure pallet. Consequently, this arrangement allows for a higher packing density of vial closures. Consequently, the alternating orientation of receptacles 120 in adjacent receptacle rows 130 allows the receptacle array 110 to occupy less space on the vial closure pallet, and thus allows the vial closure pallet to be manufactured smaller than conventional bulk pallets.

[0081] In one embodiment, the receptacle array 110 may include four spaced-apart receptacle rows 130, two of which have eight receptacles 120 and the other two have seven receptacles 120. Each receptacle 120 can be sized and shaped to accommodate a 20 mm vial seal. Thus, the receptacle array 110 can be configured to releasably receive and secure up to thirty vial seals / trays. In other embodiments, the receptacle array 110 can be configured to include more or fewer receptacle rows and associated receptacles. Although the vial seal tray is shown as a box-shaped rectangular tray, in other embodiments, the vial seal tray can be manufactured into alternative configurations suitable for its intended use, such as where the outer perimeter of the tray has a square shape, a circular shape, an oval shape, or various other shapes. In some embodiments, the 20 mm vial seal tray can be manufactured using a concave thermoforming tool.

[0082] Each individual receptacle 120 includes a generally hollow cylindrical chamber 122 that extends downward from a connecting web 140 at the tray's top surface 112 to form a sidewall 128 bounded by a closed lower end 124. A partially circular rim below the vial seal tray's upper surface 112 forms a resting support connector upon which the snaps of the vial seal rest. A narrow central protrusion or region 126 extends upward from the central region of the closed lower end 124. Region 126 includes an end portion 127 configured to provide rigidity and stability to chamber 122. In some aspects, region 126 and end portion 127 can be configured to support the vial seal when received in a generally vertical orientation within the receptacle. End portion 127 of region 126 can have a hemispherical or dome-shaped configuration, among other shapes. The shallow channels 132 connecting each receptacle 120 within a corresponding receptacle row 130 provide ample clearance or gripping space 134 between each adjacent receptacle within the row, as well as ample clearance or gripping space 135 at each end of the row proximate the corresponding receptacle.

[0083] These gripping spaces 134, 135 allow a user to manually grasp opposite sides of a vial seal disposed in a corresponding receptacle 120 to easily remove each individual vial seal from the tray using the user's fingers or a gripping tool. Furthermore, these gripping spaces 134, 135 also allow adjacent vial seals within a corresponding receptacle row to be separated to prevent or minimize contamination between the vial seals. For example, the gripping spaces 134, 135 provide sufficient clearance to allow a user to remove a single vial seal from an individual receptacle 120 in the vial seal tray by gripping the vial seal's opposite sides with the aid of the respective gripping spaces without touching or contaminating other vial seals disposed in the vial seal tray (such as vial seals disposed in adjacent receptacles 120 in a shared receptacle row 130). This type of tray configuration makes it easier for users working in small workspaces, such as biosafety cabinets, to remove individual vial seals from the tray. Immediately adjacent receptacles 120 in each receptacle row 130 are separated by shallow channels 132 , while adjacent receptacles 120 in adjacent receptacle rows 120 are separated by connecting webs 140 .

[0084] The vial closure tray 100 can be formed from one or more rigid or semi-rigid polymer materials, including but not limited to polyethylene, polycarbonate, polypropylene, and / or a composite combination of materials selected to maintain the integrity of the stored vial closures. Additionally, materials that are stable after exposure to a gamma radiation sterilization process, such as gamma-stabilized polypropylene, can be used to manufacture the vial closure tray.

[0085] exist Figures 5 to 8 Another specific implementation of a vial seal tray 200 according to the present disclosure is shown in FIG. The vial seal tray 200 includes a receptacle array 210 having a plurality of individual receptacles 220. Each individual receptacle is configured to releasably receive and secure a vial seal. The vial seal tray 200 can be disposed within a container for protecting the vial seals from contamination. For example, the container can include one or more sterile bags sized and shaped to accommodate the vial seal tray, wherein the bag is heat sealed once the tray is accommodated in the bag. The vial seal tray 200 can be accommodated in a heat-sealed primary bag having a partial vacuum applied thereto to remove excess air. According to another aspect, the vial seal tray 200 within the primary bag can be further accommodated in a secondary heat-sealed bag.

[0086] The vial seal tray 200 includes a box-shaped body having a top surface 212 of a substantially rectangular shape and a base 214 defining a stabilizing flange that protrudes outward along the periphery of the seal tray. Tray walls 216 extend between the top surface 212 and the base 214 along the periphery of the seal tray. The top surface 212 of the seal tray may include a chamfered edge 213 along its periphery to facilitate stacking with another vial seal tray. The tray walls 216 may include one or more cutouts or notches 215 to similarly facilitate stacking with another vial seal tray. Further, each corner 217 of the vial seal tray 200 may be cut away to facilitate inserting the tray into a primary bag during the packaging process. Further, the corners may also help facilitate stacking and reduce the amount of raw materials required to manufacture the tray and the associated costs.

[0087] The receptacle array 210 includes a plurality of spaced-apart linear receptacle rows 230. The plurality of receptacle rows 230 are interconnected by connecting webs 240 disposed on the top surface 212 of the vial seal tray 200. Each receptacle row 230 includes a plurality of individually spaced receptacles 220. Further, each receptacle row 230 defines a shallow channel 232 connecting each of the plurality of individually spaced receptacles 220. The shallow channel 232 defines a clearance space that allows access for tweezers or a user's fingers to facilitate removal of a vial seal from the tray, as will be discussed further below. Each receptacle 220 is configured to receive a portion of a vial seal and can be substantially cylindrical in shape. The plurality of linear receptacle rows 230 are arranged parallel to each other and spaced apart, such that the connecting webs 240 on the top surface 212 interconnect the receptacle rows 230.

[0088] The receptacle array 210 may include four spaced-apart receptacle rows 230, wherein each of the receptacle rows has ten receptacles 220. The size and shape of each receptacle 220 may be set to accommodate a 13 mm vial seal. Thus, the receptacle array 210 may be configured to releasably receive and secure up to 40 vial seals / trays. In other embodiments, the receptacle array 210 may be configured to include more or fewer receptacle rows and associated receptacles. Although the vial seal tray is shown as a box-shaped rectangular tray, in other embodiments, the vial seal tray may be manufactured into an alternative configuration suitable for its intended use, such as wherein the outer periphery of the tray has a square shape, a circular shape, an oval shape, or various other shapes. In some embodiments, the 13 mm vial seal tray may be manufactured using a convex thermoforming tool.

[0089] Each individual receptacle 220 includes a generally hollow cylindrical chamber 222 that extends downward from a connecting web 240 at the tray's top surface 212 to form a sidewall 228 bounded by a closed lower end 224. A partially circular rim below the vial seal tray's upper surface 212 forms a resting support connector upon which the snaps of the vial seal rest. A narrow central protrusion or region 226 extends upward from the central region of the closed lower end 224. Region 226 includes an end portion 227 configured to provide rigidity and stability to chamber 222. In some aspects, region 226 and end portion 227 can be configured to support the vial seal when received in a generally vertical orientation within the receptacle. End portion 227 of region 226 can have a hemispherical or dome-shaped shape, among other shapes. The shallow channels 232 connecting each receptacle 220 within a corresponding receptacle row 230 provide ample clearance or gripping space 234 between each adjacent receptacle within the row, as well as ample clearance or gripping space 235 at each end of the row proximate the corresponding receptacle.

[0090] These gripping spaces 234, 235 allow a user to manually grasp opposite sides of a vial seal disposed in a corresponding receptacle 220 to easily remove each individual vial seal from the tray using the user's fingers or a gripping tool. Furthermore, these gripping spaces 234, 235 also allow adjacent vial seals within a corresponding receptacle row to be separated to prevent or minimize contamination between vial seals. For example, the gripping spaces 234, 235 provide sufficient clearance to allow a user to remove a single vial seal from an individual receptacle 220 in the vial seal tray by gripping opposite sides of the vial seal via the corresponding gripping spaces without touching or contaminating other vial seals disposed in the vial seal tray, such as vial seals disposed in adjacent receptacles 220 in a shared receptacle row 230. This type of tray configuration makes it easier for users working in small workspaces, such as biosafety cabinets, to remove individual vial seals from the tray. Immediately adjacent receptacles 220 in each receptacle row 230 are separated by shallow channels 232 , while adjacent receptacles 220 in adjacent receptacle rows 230 are separated by connecting webs 240 .

[0091] The vial closure tray 200 can be formed from one or more rigid or semi-rigid polymer materials, including but not limited to polyethylene, polycarbonate, polypropylene, and / or a composite combination of materials selected to maintain the integrity of the stored vial closures. Additionally, materials that are stable after exposure to a gamma radiation sterilization process, such as gamma-stabilized polypropylene, can be used to manufacture the vial closure tray.

[0092] Go to Figures 9 to 12, shows a vial stopper tray 300 according to the present disclosure. The vial stopper tray 300 includes a receptacle array 310 having a plurality of individual receptacles 320. Each individual receptacle is configured to releasably receive and secure a vial stopper. Similar to the vial seal tray described above, the vial stopper tray 300 can be disposed within a container for protecting the vial stoppers from contamination. Such a container can include one or more sterile bags sized and shaped to accommodate the vial stopper tray. In some aspects, once the stopper tray is housed in the sterile bag, the sterile bag can be heat sealed. Similar to the vial seal tray discussed previously, the vial stopper tray 300 can be formed from one or more rigid or semi-rigid polymer materials, including but not limited to polyethylene, polycarbonate, polypropylene, and / or a composite combination of materials selected to maintain the integrity of the stored vial seals.

[0093] The vial stopper tray 300 includes a box-shaped body having a substantially rectangular top surface 312 and a base 314 defining a stabilizing flange that protrudes outwardly along the perimeter of the stopper tray. Tray walls 316 extend along the perimeter of the stopper tray between the top surface 312 and the base 314. The stopper tray's top surface 312 may include a chamfered edge 313 along its perimeter to facilitate stacking with another vial stopper tray. The tray walls 316 may include one or more cutouts or notches 315 to similarly facilitate stacking with another vial stopper tray. In some implementations, the tray walls 316 may extend above the top surface 312 to form a cavity to further facilitate nesting of stacked stopper trays. Furthermore, each corner 317 of the vial stopper tray 300 may be cut away to facilitate insertion of the tray into a primary bag during the packaging process. Furthermore, the corners may help facilitate stacking and reduce the amount of raw materials required and associated costs for tray manufacturing. Additionally, the tray wall 316 may include one or more corrugations 318 configured to increase the stiffness of the wall to provide increased stability to the tray.

[0094] The receptacle array 310 includes a plurality of spaced-apart linear receptacle rows 330. The plurality of receptacle rows 330 are interconnected by connecting webs 340 formed on the top surface 312 of the vial stopper tray 300. Each receptacle row 330 includes a plurality of individually spaced receptacles 320. Further, each receptacle row 330 defines a shallow channel 332 connecting each of the plurality of individually spaced receptacles 320. Each receptacle 320 is configured to receive a portion of a vial stopper and can be substantially cylindrical in shape. The plurality of linear receptacle rows 330 are arranged parallel to and spaced apart from each other, whereby the connecting webs 340 on the top surface 312 interconnect the receptacle rows 330.

[0095] The receptacle array 310 can include five spaced receptacle rows 330, wherein each receptacle row has six receptacles 320. The size and shape of each receptacle 320 can be set to accommodate 20mm vial stoppers. Thus, the receptacle array 310 can be configured to releasably receive and secure up to 30 vial stoppers / trays. In other specific implementations, the receptacle array 310 can be configured to include more or fewer receptacle rows and associated receptacles. Although the vial stopper tray is shown as a box-shaped rectangular tray, in other specific implementations, the vial stopper tray can be manufactured into an alternative configuration suitable for its intended use, such as wherein the outer periphery of the tray has a square shape, a circular shape, or an oval shape, as well as various other shapes.

[0096] Each individual receptacle 320 includes a generally hollow cylindrical chamber 322 extending downward from a connecting web 340 at the tray's top surface 312 to form a sidewall 328 bounded by a closed lower end 324. In some aspects, chamber 322 can include a first, or top, portion and a second, or bottom, portion, wherein the first, or top, portion has a larger diameter than the second, or bottom, portion. Thus, a vial stopper can be secured within the first, or top, portion while the second, or bottom, portion remains free. In some implementations, a narrow central protrusion or region can extend upward from the central region of the closed lower end 324. The protrusion can include a terminal portion configured to provide rigidity and stability to the chamber and to support the vial stopper when received within the receptacle. The terminal portion can have a hemispherical or dome-shaped configuration, among other shapes. Additionally, each receptacle 320 includes a retaining member or bumper 329 that protrudes into the corresponding chamber 322. Bumper 329 is configured to releasably secure a portion of a corresponding vial stopper within chamber 322 .

[0097] Thus, each buffer 329 serves as a retaining portion disposed at the upper end of each respective receptacle. The buffer extends radially inwardly into the chamber of the receptacle, thereby forming a contracted opening or neck of the receptacle for securing the vial stopper. For example, the vial stopper can be snapped into the respective receptacle by pushing the vial stopper until it engages with the corresponding buffer of the receptacle. Further, each receptacle may include one or more buffers 329. For example, each receptacle may include two buffers diametrically opposed to each other. The buffers limit the axial mobility of the vial stoppers housed in the respective receptacles by a forced locking engagement that securely holds the vial stoppers in a substantially vertical orientation in the receptacle while also allowing the user to pull each individual vial stopper with sufficient force to disengage the buffer and thereby remove the stopper from its respective receptacle.

[0098] The shallow channels 332 connecting each receptacle 320 within the corresponding receptacle row 330 serve a dual function. First, the channels 332 provide sufficient clearance or gripping space to facilitate manual removal of each individual vial stopper from its corresponding receptacle in the stopper tray. Second, the channels 332 allow for steam sterilization of any vial stopper disposed in the stopper tray.

[0099] Specifically, the channel 332 provides sufficient clearance or gripping space 334 between each adjacent receptacle within the row, as well as sufficient clearance or gripping space 335 near each end of the row of corresponding receptacles. For example, the gripping spaces 334, 335 allow a user to manually grasp opposite sides of a vial stopper disposed in a corresponding receptacle 320 to easily remove each individual vial stopper from the tray using the user's fingers or a gripping tool. Furthermore, these gripping spaces 334, 335 also allow adjacent vial stoppers within a corresponding row of receptacles to be spaced apart to prevent or minimize contamination between the vial stoppers.

[0100] For example, the gripping spaces 334, 335 provide sufficient clearance to allow a user to remove a single vial stopper from a separate receptacle 320 in the vial stopper tray by gripping the opposite side of the vial stopper via the respective gripping spaces without touching or contaminating other vial stoppers disposed in the vial stopper tray (such as vial stoppers disposed in adjacent receptacles 320 in a shared receptacle row 330). This type of tray configuration makes it easier for users working in small workspaces (such as biosafety cabinets) to remove individual vial stoppers from the tray. Immediately adjacent receptacles 320 in each receptacle row 330 are separated by shallow channels 332, while adjacent receptacles 320 in adjacent receptacle rows 330 are separated by connecting webs 340.

[0101] Further, the shallow channels 332 allow steam sterilization of individual vial stoppers disposed in the stopper tray. Specifically, when sterilizing steam is introduced into each channel 332, steam is allowed to flow and contact each individual vial stopper (e.g., by flowing upward and around the vial stopper) as the steam travels along the length of the corresponding channel. The empty second or bottom portion of the receptacle facilitates steam sterilization to flow along the channel and contact the underside of the vial stopper fixed in the first or top portion of the receptacle. The vial stopper tray 300 also includes one or more reinforcing ribs 350 configured to provide stability to the tray. Each reinforcing rib 350 is disposed on the top surface of the stopper tray 312 and extends across the top surface substantially perpendicular to the receptacle row 330. Through this arrangement, each reinforcing rib 350 increases the rigidity of the top surface of the tray to prevent undesirable buckling of the tray. For example, the vial stopper tray 300 may include five reinforcing ribs 350 , wherein each reinforcing rib is disposed between adjacent receptacles of a corresponding receptacle row, and further wherein each reinforcing rib extends vertically across all five receptacle rows.

[0102] refer to Figures 13 to 16 , shows another specific implementation of a vial stopper tray 400. While the vial stopper tray 400 shares various features of the vial stopper tray 300 discussed previously. More specifically, the vial stopper tray 400 includes a receptacle array 410 having a plurality of individual receptacles 420. For example, the vial stopper tray 400 may include a receptacle array 410 comprising seven spaced-apart receptacle rows 430, wherein five receptacle rows each have six receptacles 420, and the remaining two receptacle rows each have five receptacles. Each receptacle 420 can be sized and shaped to accommodate 13 mm vial stoppers. Thus, the receptacle array 410 can be configured to releasably receive and secure up to 40 vial stoppers / tray. In other specific implementations, the receptacle array 410 can be configured to include more or fewer receptacle rows and associated receptacles. Further, the vial stopper tray 400 may include a plurality of reinforcing ribs 450 , such as seven reinforcing ribs, wherein each reinforcing rib is vertically disposed on the top surface of the tray adjacent to and spaced apart from opposite sides of each receptacle of a corresponding receptacle row.

[0103] Each individual receptacle 420 of the receptacle array 410 is configured to releasably receive and secure a vial stopper. The vial stopper tray 400 can be disposed within a container for protecting the vial stoppers from contamination. Such a container can include one or more sterile bags sized and shaped to accommodate the vial stopper tray. In some aspects, once the stopper tray is contained in the sterile bag, the sterile bag can be heat-sealed. The vial stopper tray 400 can be formed from one or more rigid or semi-rigid polymer materials, including but not limited to polyethylene, polycarbonate, polypropylene, and / or a composite combination of materials selected to maintain the integrity of the stored vial stoppers.

[0104] The vial stopper tray 400 includes a box-shaped body having a substantially rectangular top surface 412 and a base 414 defining a stabilizing flange that protrudes outward along the perimeter of the stopper tray. Tray walls 416 extend along the perimeter of the stopper tray between the top surface 412 and the base 414. The stopper tray's top surface 412 may include a chamfered edge 413 along its perimeter to facilitate stacking with another vial stopper tray. The tray walls 416 may include one or more cutouts or notches 415 to similarly facilitate stacking with another vial stopper tray. In some implementations, the tray walls 416 may extend above the top surface 412 to form a cavity to further facilitate nesting of stacked stopper trays. Furthermore, each corner 417 of the vial stopper tray 400 may be cut away to facilitate insertion of the tray into a primary bag during the packaging process. Furthermore, the corners may help facilitate stacking and reduce the amount of raw materials required and associated costs for tray manufacturing. Additionally, the tray wall 416 may include one or more corrugations 418 configured to increase the stiffness of the wall to provide increased stability to the tray.

[0105] The receptacle array 410 includes a plurality of spaced-apart linear receptacle rows 430. The plurality of receptacle rows 430 are interconnected by connecting webs 440 formed on the top surface 412 of the vial stopper tray 400. Each receptacle row 430 includes a plurality of individually spaced receptacles 420. Further, each receptacle row 430 defines a shallow channel 432 connecting each of the plurality of individually spaced receptacles 420. Each receptacle 420 is configured to receive a portion of a vial stopper and can be substantially cylindrical in shape. The plurality of linear receptacle rows 430 are arranged parallel to and spaced apart from each other, whereby the connecting webs 440 on the top surface 412 interconnect the receptacle rows 430.

[0106] Each individual receptacle 420 includes a generally hollow cylindrical chamber 422 that extends downward from a connecting web 440 at the tray's top surface 412 to form a sidewall 428 bounded by a closed lower end 424. In some aspects, chamber 422 may include a first or top portion and a second or bottom portion, wherein the first or top portion has a larger diameter than the second or bottom portion. In some aspects, a narrow central protrusion or region may extend upward from the central region of closed lower end 424. The protrusion may include an end portion configured to provide rigidity and stability to the tray and to support the vial stopper when received within the receptacle. The end portion may have a hemispherical or dome-shaped configuration, among other shapes. In addition, each receptacle 420 includes a retaining member or bumper 429 that protrudes into the corresponding chamber 422. The bumper 429 is configured to releasably secure a portion of the corresponding vial stopper within the chamber 422.

[0107] Each buffer 429 serves as a retaining portion disposed at the upper end of each corresponding receptacle. The buffer extends radially inwardly into the chamber of the receptacle, thereby forming a contracted opening or neck of the receptacle for securing the vial stopper. For example, the vial stopper can be snapped into the corresponding receptacle by pushing the vial stopper until it engages with the corresponding buffer of the receptacle. Further, each receptacle may include one or more buffers 429. For example, each receptacle may include two buffers diametrically opposed to each other. The buffers limit the axial mobility of the vial stoppers housed in the corresponding receptacle by a forced locking engagement that securely holds the vial stoppers in a substantially vertical orientation in the receptacle while also allowing the user to pull each individual vial stopper with sufficient force to disengage the buffer and thus remove the stopper from its corresponding receptacle.

[0108] The shallow channels 432 connecting each receptacle 420 within the corresponding receptacle row 430 serve a dual function. First, the channels 432 provide sufficient clearance or gripping space to facilitate manual removal of each individual vial stopper from its corresponding receptacle in the stopper tray. Second, the channels 432 allow for steam sterilization of any vial stopper disposed in the stopper tray.

[0109] Specifically, the channel 432 provides sufficient clearance or gripping space 434 between each adjacent receptacle within the row, as well as sufficient clearance or gripping space 435 near each end of the row of corresponding receptacles. For example, the gripping spaces 434, 435 allow a user to manually grasp opposite sides of a vial stopper disposed in a corresponding receptacle 420 to easily remove each individual vial stopper from the tray using the user's fingers or a gripping tool. Furthermore, these gripping spaces 434, 435 also allow adjacent vial stoppers within a corresponding row of receptacles to be separated to prevent or minimize contamination between the vial stoppers.

[0110] For example, the gripping spaces 434, 435 provide sufficient clearance for a user to remove a single vial stopper from a separate receptacle 420 in the vial stopper tray by gripping the opposite side of the vial stopper via the respective gripping spaces without touching or contaminating other vial stoppers disposed in the vial stopper tray, such as vial stoppers disposed in adjacent receptacles 420 in a shared receptacle row 430. This type of tray configuration makes it easier for users working in small workspaces (such as biosafety cabinets) to remove individual vial stoppers from the tray. Immediately adjacent receptacles 420 in each receptacle row 430 are separated by shallow channels 432, while adjacent receptacles 420 in adjacent receptacle rows 430 are separated by connecting webs 440.

[0111] Further, the shallow channels 432 allow steam sterilization of individual vial stoppers disposed in the stopper tray. Specifically, when sterilizing steam is introduced into each channel 432, steam is allowed to flow and contact each individual vial stopper (e.g., by flowing upward and around the vial stopper) as the steam travels along the length of the corresponding channel. The vial stopper tray 400 also includes one or more reinforcing ribs 450 configured to provide stability to the tray. Each reinforcing rib 450 is disposed on the top surface of the stopper tray 412 and extends across the top surface substantially perpendicular to the receptacle rows 430. Through this arrangement, each reinforcing rib 450 increases the rigidity of the top surface of the tray to prevent undesirable buckling of the tray. For example, the vial stopper tray 400 may include five reinforcing ribs 450, each of which is disposed between adjacent receptacles of the corresponding receptacle rows, and further, each of which extends vertically across all five receptacle rows.

[0112] refer to Figures 17 to 21 , shows another embodiment of a vial stopper tray 400a that shares various features of the vial stopper tray 400 discussed previously. A stopper tray cover or lid 460 is configured to be removably attached to the vial stopper tray 400a to secure and protect the vial stoppers disposed in the vial stopper tray 400a. The vial stopper tray 400a includes a receptacle array 410a having a plurality of individual receptacles 420a. For example, the vial stopper tray 400a may include a receptacle array 410a comprising seven spaced-apart receptacle rows 430a, five of which each have six receptacles, and the remaining two receptacle rows each have five receptacles. Each receptacle 420a can be sized and shaped to accommodate a 13 mm vial stopper. Thus, the receptacle array 410a can be configured to releasably receive and secure up to forty vial stoppers / trays. In other embodiments, the receptacle array 410a can be configured to include more or fewer receptacle rows and associated receptacles. Further, the vial stopper tray 400a can include a plurality of reinforcing ribs 450a, such as seven reinforcing ribs, wherein each reinforcing rib is vertically disposed on the top surface of the tray, adjacent to and spaced from opposite sides of each receptacle of a corresponding receptacle row.

[0113] Each individual receptacle 420a of the receptacle array 410a is configured to releasably receive a corresponding vial stopper. The vial stopper tray 400a includes a box-shaped body having a substantially rectangular top surface 412a and a base 414a defining a stabilizing flange that protrudes outwardly along the perimeter of the stopper tray. A tray wall 416a extends along the perimeter of the vial stopper tray between the top surface 412a and the base 414a. One or more cutouts or recesses 415a may be provided on the interior side of the tray wall 416a for receiving corresponding protrusions 462a of the lid 460. In some implementations, the tray wall 416a may extend above the top surface 412a to form a cavity to facilitate nesting the lid 460 on top of the vial stopper tray.

[0114] The receptacle array 410a includes a plurality of spaced-apart linear receptacle rows 430a. The plurality of receptacle rows 430a are interconnected by connecting webs 440a formed on the top surface 412a of the vial stopper tray 400a. Each receptacle row 430a includes a plurality of individually spaced receptacles 420a. Further, each receptacle row 430a defines a shallow channel 432a connecting each of the plurality of individually spaced receptacles 420a. Each receptacle 420a is configured to receive a portion of a vial stopper and may be substantially cylindrical in shape. The plurality of linear receptacle rows 430a are arranged parallel to and spaced apart from each other, whereby the connecting webs 440a on the top surface 412a interconnect the plurality of receptacle rows 430a.

[0115] Each individual receptacle 420a includes a generally hollow cylindrical chamber 422a that extends downwardly from a connecting web 440a at the tray's top surface 412a to form a sidewall 428a bounded by a closed lower end 424a. In some aspects, chamber 422a can include a first or top portion and a second or bottom portion, wherein the first or top portion has a larger diameter than the second or bottom portion. Thus, a vial stopper can be secured within the first or top portion while the second or bottom portion remains empty.

[0116] The shallow channels 432a connecting each receptacle 420a within the corresponding receptacle row 430a serve a dual function. First, the channels 432a provide sufficient clearance or gripping space to facilitate manual removal of each individual vial stopper from its corresponding receptacle in the stopper tray. Second, the channels 432a allow for steam sterilization of any vial stopper disposed in the stopper tray.

[0117] Specifically, channel 432a provides sufficient clearance or gripping space 434a between each adjacent receptacle within the row, as well as sufficient clearance or gripping space 435a at each end of the row near the corresponding receptacle. For example, gripping spaces 434a, 435a allow a user to manually grasp opposite sides of a vial stopper disposed in a corresponding receptacle 420a to easily remove each individual vial stopper from the tray using the user's fingers or a gripping tool. Furthermore, these gripping spaces 434a, 435a also allow adjacent vial stoppers within a corresponding row of receptacles to be separated, thereby preventing or minimizing contamination between the vial stoppers.

[0118] In one embodiment, the vial stopper tray of the invention is provided with a plurality of vial stoppers, the plurality of vial stoppers being provided in the tray. For example, the clamping spaces 434a, 435a provide enough clearances, which allow the user to remove a single vial stopper from the independent receptacle 420a in the vial stopper tray by clamping the opposite side of the vial stopper via the corresponding clamping space, without touching or contaminating other vial stoppers arranged in the vial stopper tray, such as the vial stoppers arranged in the adjacent receptacle 420a in the shared receptacle row 430a. This type of tray configuration makes it easier for the user working in a small workspace (such as a biosafety cabinet) to remove independent vial stoppers from the tray. The adjacent receptacle 420a in each receptacle row 430a is separated by shallow passage 432a, and the adjacent receptacle 420a in the adjacent receptacle row 430a is separated by connecting web 440a. Further, shallow passage 432a allows the independent vial stoppers arranged in the stopper tray to be steam sterilized. Specifically, when sterilizing steam is introduced into each channel 432a, the steam is permitted to flow into contact with each individual vial stopper (e.g., by flowing upward and around the vial stopper) as it travels along the length of the corresponding channel. The empty second or bottom portion of the receptacle facilitates the flow of sterilizing steam along the channel and into contact with the underside of the vial stopper secured within the first or top portion of the receptacle.

[0119] The vial stopper tray 400a also includes one or more reinforcing ribs 450a configured to provide stability to the tray. Each reinforcing rib 450a is disposed on the top surface of the stopper tray 412a and extends across the top surface substantially perpendicular to the receptacle rows 430a. Through this arrangement, each reinforcing rib 450a increases the rigidity of the tray's top surface to prevent undesirable buckling of the tray. For example, the vial stopper tray 400a may include five reinforcing ribs 450a, each of which is disposed between adjacent receptacles in a corresponding receptacle row. Each reinforcing rib 450a may also extend vertically across all five receptacle rows.

[0120] The stopper tray cover 460 is configured to be removably attached to the vial stopper tray 400a to secure and protect vial stoppers placed in corresponding receptacles 420a of the stopper tray. The stopper tray cover 460 includes a cover base 461 having a sidewall 462 extending along its perimeter. One or more locking protrusions 462a extend from a portion of the sidewall 462 to matingly engage corresponding cutouts or notches 415a provided on the interior side of the tray sidewall 416a to releasably secure the stopper tray cover to the stopper tray. For example, an interference fit may be formed between the locking protrusions 462a and the notches 415a. A cover flange 464 protrudes outwardly from the sidewall 462 along the perimeter of the tray cover. The cover flange 464 may include an enlarged gripping portion 464a to assist a user in separating the stopper tray cover from the stopper tray.

[0121] The bottom surface of the lid base 461 includes a plurality of retaining areas 466 protruding therefrom, each of which corresponds to a corresponding receptacle 420a of the stopper tray 400a. Each retaining area 466 is sized and shaped to fit within the corresponding receptacle 420a when the stopper tray lid is attached to the stopper tray. Further, each retaining area 466 includes an end portion 467 configured to retain a vial stopper in position within the corresponding receptacle 420a of the stopper tray when the stopper tray lid is attached to the stopper tray. Each end portion 467 can be substantially flat to maximize the surface area in contact with the corresponding vial stopper.

[0122] One or more lid reinforcement ribs 468 may be provided on the lid base 461 to provide stability to the tray lid. Each lid reinforcement rib 468 may protrude from the bottom surface of the lid base. In addition, each lid reinforcement rib 468 may extend across the lid base in a direction substantially perpendicular to the receptacle rows 430a. For example, the lid reinforcement rib 468 may extend in the same direction as the reinforcement ribs 450a of the stopper tray. With this arrangement, each lid reinforcement rib 468 increases the rigidity of the lid base to prevent it from unwanted buckling. In some embodiments, for example, the tray lid may include a plurality of lid reinforcement ribs 468 corresponding to the plurality of reinforcement ribs 450a of the stopper tray.

[0123] After the tray cover 460 is attached to the vial stopper tray 400a, they can be stored in a container, such as a sterile bag. In some aspects, once the stopper tray assembly is contained in the sterile bag, the sterile bag can be heat sealed. Additionally, both the vial stopper tray 400 and the tray cover 460 can be formed from one or more rigid or semi-rigid polymeric materials, including but not limited to polyethylene, polycarbonate, polypropylene, and / or a composite combination of materials selected to maintain the integrity of the stored vial stoppers.

[0124] In a further embodiment, a kit can be provided that includes various combinations of the aforementioned vial seal trays and vial stopper trays, as well as a vial tray that accommodates a corresponding number of pharmaceutical vials. For example, such a collection of trays can form a small number of kits suitable for biofilling, etc. Therefore, such kits allow users to easily access individual vial seals and vial stoppers from their respective trays when working in a small workspace (such as a biosafety cabinet or a laboratory table with a hood). When compared with conventional seal and / or stopper packaging methods, such kit arrangements make it easier for users to assemble seals and stoppers on corresponding vials. In addition, such kits advantageously eliminate or minimize the risk of contamination of component vial seals and vial stoppers because the user can remove each unit individually from its corresponding tray. Specifically, the various vial seal trays, vial stopper trays, and vial trays permit the corresponding seals, stoppers, and vials to be presented to the biosafety cabinet operator in an efficient orientation for use in a space-saving rack-like structure (i.e., by facilitating the gripping, carrying, and placement of each seal and stopper onto the corresponding vial). For example, the vial seals can be oriented with their plastic snaps facing upward, and the vial stoppers can be oriented with their top flanges facing upward. In contrast, vial closures dumped from conventional bulk packaging onto a work surface will not be presented in the correct orientation because some vial closures will land upside down or on their side.

[0125] Figures 22 to 25 A specific implementation of a vial tray assembly 500 is shown, comprising a base 510 defining a generally box-like shape having a bottom wall 512 and sidewalls 514 extending along the periphery of the base. The upper surface of the sidewall 514 is in the form of a generally planar flange 516 extending laterally outward from the sidewall. The bottom wall 512 defines a vial holder array 518 comprising a plurality of receptacles 520. Each receptacle 520 is configured to securely and releasably receive a single vial, enabling a plurality of vials 600 to be held in a spaced array. The vial holder array 518 comprises a plurality of spaced-apart rectilinear receptacle rows 530 interconnected by connecting webs 540. Each receptacle row 530 comprises a plurality of individually spaced receptacles 520. Further, each receptacle row 530 defines a channel 532 connecting each of the plurality of individually spaced receptacles 520.

[0126] Each receptacle 520 is configured to receive the top portion of a corresponding vial. In other words, the vial is inserted upside down into the corresponding receptacle. In one embodiment, the vial holder array 518 may include five spaced-apart receptacle rows 530, each row having five spaced-apart receptacles 520. Each receptacle 520 may be sized and shaped to accommodate a vial of a corresponding size and shape. Thus, the vial holder array 518 may be configured to releasably receive and secure up to 25 vials per tray. In other embodiments, the vial holder array 518 may be configured to include more or fewer receptacle rows and associated receptacles. Although the vial tray is shown as a box-shaped square tray, in other embodiments, the vial tray may be manufactured in alternative configurations suitable for its intended use, such as wherein the outer perimeter of the tray has a rectangular, circular, or oval shape, as well as various other shapes.

[0127] Each individual receptacle 520 includes a generally hollow chamber 522 defined by a connecting web 540, forming a closed lower end 524. A centrally located protrusion or region 526, forming a center post, extends upward from the central region of the closed lower end 524. Region 526 is configured to support the vial when received in a generally vertical orientation within the receptacle 520. Region 526 may be generally cross-shaped, among other shapes. Each receptacle has a cross-section configured to securely and releasably hold a single vial. In some implementations, this can be achieved through a clearance fit, with each center post helping to control the position of a corresponding vial. Channels 532 connecting each receptacle 520 within a corresponding receptacle row 530 provide sufficient clearance between each adjacent receptacle within the row. In other implementations, the vial may be secured via an interference fit. In further implementations, the center post may be omitted.

[0128] Additionally, the vial tray assembly 500 may also include a vial tray cover or lid 550 that includes a plurality of downwardly facing recesses 554 spaced apart from one another at the same spacing as the vials in the vial holder array 518. As the vials are inverted within each corresponding receptacle 520 of the vial tray, each recess 554 of the lid is arranged to retain a bottom portion of a corresponding vial. The outer periphery of the vial tray cover 550 is shaped and sized to fit within the open portion of the base 510 to close the base and thereby seal the vials therein.

[0129] Similar to the vial seal tray and vial stopper tray described previously, the vial tray assembly 500 can be formed from one or more rigid or semi-rigid polymer materials, including but not limited to polyethylene, polycarbonate, polypropylene, and / or a composite combination of materials selected to maintain the integrity of the stored vials. Additionally, materials that are stable after exposure to a gamma radiation sterilization process, such as gamma-stabilized polypropylene, can be used to manufacture the vial tray.

[0130] Figures 26 to 30 Another embodiment of a vial tray assembly 500a is shown, comprising a base tray 510a having a generally planar flange 516a extending laterally outwardly along the periphery of the base tray. A bottom portion 512a defines a vial holder array 518a comprising a plurality of receptacles 520a. Each receptacle 520a is configured to securely and releasably receive a single vial, enabling a plurality of vials 600 to be held in a spaced array. The vial holder array 518a comprises a plurality of spaced linear receptacle rows 530a interconnected by connecting webs 540a. Each receptacle row 530a comprises a plurality of individually spaced receptacles 520a. Further, each receptacle row 530a defines a channel 532a connecting each of the plurality of individually spaced receptacles 520a.

[0131] Each receptacle 520a is configured to receive the top portion of a corresponding vial. Thus, the vial is inserted upside down into the corresponding receptacle 520a. In one embodiment, the vial holder array 518a may include five separated receptacle rows 530a, wherein each receptacle row has five separated receptacles 520a. The size and shape of each receptacle 520a can be set to accommodate a vial of a corresponding size and shape. Thus, the vial holder array 518a can be configured to releasably receive and secure up to 25 vials / tray. In other embodiments, the vial holder array 518a can be configured to include more or fewer receptacle rows and associated receptacles.

[0132] Each individual receptacle 520a includes a generally hollow chamber 522a defined by a connecting web 540a to form a closed lower end 524a. The bottom surface of the chamber 522a can be planar to ensure sufficient contact area with the top portion of the vial. In some implementations, each receptacle can be configured to securely and releasably retain a single vial via an interference fit. The channel 532a connecting each receptacle 520a within the corresponding receptacle row 530a provides sufficient clearance between each adjacent receptacle within the row.

[0133] Additionally, the vial tray assembly 500a may include a vial tray cover or lid 550a configured to releasably attach to the base tray 510a, such as via a snap fit in some implementations. In other implementations, a vacuum bag may hold the tray and lid together, with their relative positions controlled in the lateral directions (i.e., the x and y directions; the z direction does not interfere as it is releasable) by segmented walls extending around the edges of the lid. These segmented walls are interrupted by a cutout portion in the middle of each edge. The vial tray cover 550a further includes a plurality of lid receptacles 560a corresponding to respective receptacles 520a of the base tray 510a. Each lid receptacle 560a includes a generally hollow chamber 562a defined by a connecting web 564a and forms a closed upper end 566a having a planar surface that ensures sufficient contact area with the bottom portion of the vial. In some embodiments, each lid receptacle can be configured to securely and releasably hold a single vial via an interference fit. The channel 568a connecting each lid receptacle 560a provides sufficient clearance between each adjacent receptacle in the row. Therefore, when the top portion of a vial is placed into the receptacle 520a of the base tray 510a, the tray cover 550a can be attached to the base tray 510a in such a way that the bottom portion of the vial is received in the corresponding receptacle 560a of the tray cover. The closed upper end 566a of the tray cover contacts the bottom portion of the corresponding vial to secure it in place. Therefore, when the vial tray assembly is closed, it can present the vials in different orientations, such as with the vials oriented with their top portions facing upward or their top portions facing downward. This also allows the vial tray or the vial tray cover to be removed without contacting each other.

[0134] Although certain specific implementations of the vial seal tray, vial stopper tray, vial tray, and associated kits have been described in terms of what may be considered specific aspects, the present disclosure is not limited to the disclosed aspects. Additional modifications and improvements to the aforementioned trays and kits may be apparent to those skilled in the art. Moreover, many features and advantages of the present disclosure are apparent from the detailed description, and, therefore, the appended claims are intended to cover all such features and advantages of the present disclosure that fall within the spirit and scope of the present disclosure.

Claims

1. A vial closure tray, comprising: a body having a top surface defining a receptacle array, the receptacle array comprising a plurality of receptacle rows, each of the plurality of receptacle rows comprising a plurality of individual, spaced-apart receptacles configured to releasably secure a corresponding vial seal; a connecting web disposed on the top surface of the vial closure tray and interconnecting a plurality of individual receptacles, each receptacle defining a hollow cavity extending downwardly from the top surface of the vial closure tray and forming a closed lower end, the hollow cavity being configured to receive a portion of the vial closure; an area projecting upwardly from a central portion of the closed lower end of each receptacle for supporting the vial seal; and A channel extends through the plurality of individually spaced receptacles disposed in each respective receptacle row, the channel forming gaps on opposing sides of each receptacle to facilitate gripping of the vial seal retained in the corresponding receptacle. 2 . The vial closure pallet of claim 1 , wherein the plurality of receptacle rows are arranged parallel to each other and laterally offset from each other such that each receptacle in adjacent receptacle rows is correspondingly offset from each other.

3. The vial closure pallet of any preceding claim, wherein the vial closure pallet comprises a base defining a flange projecting outwardly along a periphery of the vial closure pallet. 4 . The vial closure tray of claim 3 , further comprising a tray wall extending along the perimeter of the vial closure tray between the top surface and the base.

5. The vial closure tray according to any one of the preceding claims, wherein the top surface of the vial closure tray includes a chamfered edge along its perimeter.

6. A vial stopper tray, comprising: a body having a top surface defining a receptacle array, the receptacle array comprising a plurality of receptacle rows, each of the plurality of receptacle rows comprising a plurality of individual, spaced-apart receptacles configured to releasably secure a corresponding vial stopper; a connecting web disposed on the top surface of the vial stopper tray and interconnecting a plurality of individual receptacles, each receptacle defining a hollow cavity extending downwardly from the top surface of the vial stopper tray and forming a closed lower end, the hollow cavity being configured to receive a portion of the vial stopper; an area projecting upwardly from a central portion of the closed lower end of each receptacle for supporting the vial stopper; and A channel extends through the plurality of individually spaced receptacles disposed in each respective receptacle row, the channel forming gaps on opposing sides of each receptacle to facilitate gripping of the vial stopper retained in the corresponding receptacle.

7. The vial stopper tray of claim 6, wherein each receptacle includes a bumper configured to releasably secure a portion of a corresponding vial stopper within the cavity.

8. The vial stopper tray of claim 7, wherein the bumper extends radially inwardly from an inner wall of the receptacle, the bumper forming a constricted opening to the cavity.

9. The vial stopper tray according to any one of claims 6 to 8, wherein the channel is further configured to permit steam to flow along the receptacle row for sterilizing each vial stopper disposed in the receptacle row. 10 . The vial stopper tray according to claim 6 , further comprising a reinforcing rib provided on the top surface of the vial stopper tray and extending perpendicularly to the channel for increasing the rigidity of the top surface of the vial stopper tray.

11. The vial stopper tray according to any one of claims 6 to 10, wherein the vial stopper tray comprises a base defining a flange projecting outwardly along a periphery of the vial stopper tray.

12. The vial stopper tray of claim 11, further comprising a tray wall extending along the perimeter of the vial stopper tray between the top surface and the base.

13. The vial stopper tray according to any one of claims 6 to 12, wherein the vial stopper tray comprises chamfered edges along its periphery.

14. The vial stopper tray according to any one of claims 6 to 13, further comprising a stopper tray cover configured to be removably attached to the body of the vial stopper tray.

15. The vial stopper tray of claim 14, wherein the stopper tray cover comprises a cover base having a side wall extending along a periphery of the cover base, and a locking protrusion extending from a portion of the side wall for matingly engaging a portion of the body of the vial stopper tray.

16. The vial stopper tray of claim 14, wherein the stopper tray cover comprises a bottom surface having a plurality of retaining areas protruding therefrom, wherein each retaining area is sized and shaped to fit within a corresponding receptacle of the vial stopper tray when the stopper tray cover is attached to the stopper tray.

17. A kit comprising: A vial tray, the vial tray comprising: a tray base having a vial receptacle array comprising a plurality of vial receptacle rows, each of the plurality of vial receptacle rows comprising a plurality of individually spaced-apart vial receptacles configured to receive top portions of respective vials; and A vial closure tray, the vial closure tray comprising: a seal tray body having a top surface defining a seal receptacle array, the seal receptacle array comprising a plurality of seal receptacle rows, each of the plurality of seal receptacle rows comprising a plurality of individual, spaced-apart seal receptacles configured to receive a corresponding vial seal, and a seal channel extending through a plurality of individually spaced seal receptacles disposed in each respective seal receptacle row, the seal channel forming gaps on opposing sides of each seal receptacle to facilitate gripping of the vial seal retained in the corresponding receptacle; and A vial stopper tray, comprising: a stopper tray body having a top surface defining a stopper receptacle array, the stopper receptacle array comprising a plurality of stopper receptacle rows, each of the plurality of stopper receptacle rows comprising a plurality of individual, spaced-apart stopper receptacles configured to receive corresponding vial stoppers, and A stopper channel extends through a plurality of individually spaced stopper receptacles disposed in each respective stopper receptacle row, the stopper channel forming gaps on opposing sides of each stopper receptacle to facilitate gripping of the vial stopper retained in the corresponding receptacle.

18. The kit of claim 17, wherein the vial tray further comprises a vial tray cover comprising a plurality of recesses arranged to receive bottom portions of respective vials.

19. The kit of claim 18, wherein the outer periphery of the vial tray cover is shaped and sized to fit within the open portion of the tray base for sealing each vial within the vial tray.

20. The kit of any one of claims 17 to 19, further comprising a primary container configured to receive the vial closure tray and a secondary container configured to receive the vial closure tray and the primary container.

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