WO2023039126A1

WO2023039126A1 - Blow-fill-seal (bfs) vials with modified fluid seals, and systems and methods for fabrication thereof

Info

Publication number: WO2023039126A1
Application number: PCT/US2022/042994
Authority: WO
Inventors: Jeff Price
Original assignee: Koska Family Limited
Priority date: 2021-09-09
Filing date: 2022-09-09
Publication date: 2023-03-16

Abstract

A blow-fill-seal (BFS) vial, such as a pre-filled container containing a vaccine or other medicament, includes a modified fluid seal along a parting line of the vial. For example, the modified fluid seal can be an end portion of the BFS vial that has been thickened or otherwise strengthened during the BFS molding process. Molding systems and methods for thickening and/or strengthening the fluid seal along the parting line of the vial are also provided.

Description

BLOW-FILL-SEAL (BFS) VIALS WITH MODIFIED FLUID SEALS, AND SYSTEMS AND METHODS FOR FABRICATION THEREOF

CROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application claims benefit of and priority under 35 U.S.C. §119(e) to, and is a Non-provisional of, U.S. Provisional Patent Application No. 63/242,264 filed on September 9, 2021 and titled “Blow-Fill-Seal (BFS) Vials with Improved Fluid Seals, and Systems and Methods for Fabrication Thereof,” which is hereby incorporated by reference herein in its entirety.

TECHNICAL FIELD

[0002] The present disclosure describes systems, methods, and devices for fabricating blow-fill-seal (BFS) vials, for example, BFS vials having modified fluid seals. In accordance with some embodiments, a BFS machine may employ mold halves that are constructed to thicken a portion of the BFS vial at the parting line, which portion can be used as a fluid seal through which a needle is inserted for administering contents of the BFS vial.

BACKGROUND

[0003] Blow-Fill-Seal (BFS) manufacturing is an advanced aseptic manufacturing technique first developed in the 1930’s which has been utilized to produce various forms of plastic products in the United States since the 1960’s. Recently, BFS manufacturing has been utilized to introduce cutting-edge pharmaceutical delivery products such as those offered by ApiJect™ Systems, Inc. of Stamford, CT, which provides many advantages with respect to the standard multi-dose glass vials and separate syringes utilized for medicament storage and delivery. The basic BFS process includes: (1) vertically extruding a plastic resin to form a continuous tube of molten plastic (referred to as a “parison”), (2) engaging the parison with a multi-part primary mold (e.g., to shape desired product receptacles), (3) filling the shaped receptacles with a desired fluid via filling mandrels, (4) engaging the parison with a multi-part secondary mold (e.g., to seal the receptacles), and (5) labeling, inspection, packaging, storage, and/or distribution. There are two distinct types of BFS machines currently in use: (i) shuttle machines (e.g., ASEP-TECH® Blow/Fill/Seal machines such as the Model 640 from Weiler™ Engineering, Inc. of Elgin, IL) and (ii) rotary machines (e.g., a Bottelpack™ bp434 and/or Bottelpack™ bp460 machine from Rommelag Kunststoff-Maschinen Vertriebsgesellschaft mbH of Waiblingen, Germany).

SUMMARY OF VARIOUS EMBODIMENTS

[0004] Embodiments of the disclosed subject matter provide blow-fill-seal (BFS) vials (also referred to herein as BFS bottles or BFS containers) with modified fluid seals, for example, along a parting line pierced by a needle of an administration assembly. In some embodiments, the modified fluid seal can be an end portion of the BFS vial that has been thickened or otherwise strengthened during the BFS molding process, for example, using a rotary BFS machine. A thickened or strengthened seal may be desirable and/or advantageous in some applications, uses, or circumstances. Embodiments of the disclosed subject matter also provide molding systems and/or methods for thickening and/or strengthening the fluid seal along the parting line of the BFS vial.

[0005] In one or more embodiments, a BFS assembly can comprise at least one BFS vial. Each BFS vial can comprise a first chamber containing a fluid therein and a neck portion in fluid communication with the first chamber. The BFS vial can have a first end and a second end along a longitudinal direction. The first chamber can be disposed between the second end and the neck portion along the longitudinal direction. The neck portion can have a first wall at the first end of the BFS vial that defines a fluid seal. The BFS vial can have a parting line defined by a first plane parallel to the longitudinal direction. The first wall defining the fluid seal can have, at the parting line, a first thickness along the longitudinal direction. The first chamber can be defined by a second wall extending along the longitudinal direction. The second wall can have a second thickness along a radial direction perpendicular to the longitudinal direction. The first thickness can be greater than the second thickness.

[0006] In one or more embodiments, a method for fabricating a blow-fill-seal (BFS) assembly comprising at least one BFS vial can comprise providing a plurality of molds in a rotary BFS machine. Each mold can comprise a first mold half with a first mold pattern a second mold half with a second mold pattern. The first mold pattern can be a mirror image of the second mold pattern. Each of the first and second mold patterns can have a first pattern portion constructed to define a neck portion and a first chamber of each BFS vial. The first pattern portion can comprise, for each BFS vial, a first recess, a second recess, a pinch surface, a dam surface, and a relief surface. The first recess can be for forming at least part of the first chamber, and the second recess can be for forming the neck portion. The pinch surface can be disposed at and substantially parallel to a contact plane of the respective mold half and bounding at least a portion of the second recess. The dam surface can be disposed on a side of the pinch surface opposite from the second recess and connected to the pinch surface via a first angled surface. The dam surface can be substantially parallel to the contact plane and spaced from the contact plane by a first distance. The relief surface can be disposed on a side of the dam surface opposite from the pinch surface and connected to the dam surface via a second angled surface. The relief surface can be substantially parallel to the contact plane and spaced from the contact plane by a second distance greater than the first distance. The method can further comprise molding, using a first mold of the plurality of molds in the rotary BFS machine, molten plastic to form the neck portion and the first chamber of each BFS vial of the BFS assembly. At least the pinch and dam surfaces can urge portions of the molten plastic toward the pinch surfaces of the first and second mold halves so as to thicken a wall of the BFS vial at a part of the neck portion along a parting line between the mold halves. The method can also comprise filling the first chamber of each BFS vial with a respective fluid. The method can further comprise sealing, using a second mold of the plurality of molds in the rotary BFS machine, the first chamber of BFS vial with the fluid therein. [0007] Any of the various innovations of this disclosure can be used in combination or separately. This summary is provided to introduce a selection of concepts in a simplified form that are further described below in the detailed description. This summary is not intended to identify key features or essential features of the claimed subject matter, nor is it intended to be used to limit the scope of the claimed subject matter. The foregoing and other objects, features, and advantages of the disclosed technology will become more apparent from the following detailed description, which proceeds with reference to the accompanying figures.

BRIEF DESCRIPTION OF THE DRAWINGS

[0008] The figures depict embodiments for purposes of illustration only. The accompanying figures are not necessarily drawn to scale, emphasis instead being placed upon illustrating the principles disclosed herein. The figures are included to further the understanding of the various aspects and embodiments and are incorporated in and constitute a part of this specification, but are not intended as a definition of the limits of any particular embodiment. In the figures, each identical or nearly identical component that is illustrated in various figures is represented by a like numeral. For purposes of clarity, not every component may be labeled in every figure. One skilled in the art will readily recognize from the following description that alternative embodiments of the examples illustrated herein may be employed without departing from the principles described herein, wherein:

FIG. 1 A is a plan view of a pack of exemplary blow-fill-seal (BFS) containers, according to one or more embodiments of the disclosed subject matter;

FIGS. 1 B-1 D are side, plan, and cross-sectional views, respectively, of an exemplary BFS container, according to one or more embodiments of the disclosed subject matter;

FIGS. 1 E-1 F are close-up plan and perspective cross-sectional views, respectively, of the BFS container of FIGS. 1 B-1 D;

FIGS. 2A-2B are simplified schematic diagrams of an exemplary rotary BFS machine that can be used to form the BFS containers of FIGS. 1 A-1 F;

FIGS. 3A-3C are plan and magnified views of a patterned molding surface of an exemplary mold half for use in a rotary BFS machine, according to one or more embodiments of the disclosed subject matter;

FIG. 3D-3E are further magnified and perspective views showing the neck portions of the exemplary mold half of FIGS. 3A-3C;

FIGS. 3F-3G show cross-sectional profiles of a neck-portion-forming part of the exemplary mold half of FIGS. 3B-3E;

FIGS. 4A-4B are magnified and perspective views showing neck portions of a comparative rotary BFS mold half; and

FIG. 5 is a process flow diagram of an exemplary fabrication process employing a rotary BFS machine, according to one or more embodiments of the disclosed subject matter. DETAILED DESCRIPTION

I. Introduction

[0009] Recent advancements by the Applicant have exemplified the ability of blow-fill-seal (BFS) vials to be advantageously utilized to dispense fluids, such as a medicament (e.g., a vaccine, a drug, a therapeutic agent, a diluent, an active ingredient, and/or a component of any of the foregoing), for example, via medical injection mechanisms. However, unlike conventional BFS containers used for medicaments, a needle of an administration component pierces or punctures a sealed end of the BFS vials to access the fluid therein for injection. Compression of a body of the BFS vial forces the fluid through the needle of administration component for injection. In some applications, uses, or circumstances, the BFS vial may be susceptible to leakage of fluid around the needle and/or through a parting line of the BFS vial. In some embodiments, the volume of fluid in the BFS vial is small (e.g., less than or equal to 1-mL, for example, ~0.6-mL), such that any leakage may significantly affect the total volume of fluid (and thus medicament dosage) delivered to a patient. Applicant has developed various innovations to minimize, obviate, and/or at least reduce such potential leakage concerns, some of which are disclosed herein. For example, in some embodiments of the disclosed subject matter, the BFS vial can be thickened or otherwise strengthened at a sealed end thereof to reduce the chance of fluid leakage, despite piercing of the sealed end and subsequent pressurization of the BFS vial for administration. In some embodiments, the fluid seal can be an end portion of the BFS vial that has been modified during the BFS molding process. In some embodiments, the features of molds in a rotary BFS machine are designed to urge molten plastic toward the fluid seal end of the BFS vial during the molding process to modify (e.g., thicken or otherwise strengthen) the fluid seal.

II. BFS vials

[0010] Referring initially to FIGS. 1A-1 F, various views of a BFS assembly 100 (also referred to herein as a prefilled medical vial assembly, card, or cartridge) according to one or more embodiments of the disclosed subject matter are shown. In the illustrated example, the BFS assembly 100 comprises various inter-connected and/or modular components, an array of individual BFS vials 102a-102e connected together at adjacent lateral edges thereof. In some embodiments, the BFS assembly 100 may comprise an array of at least five (5) individual BFS vials, for example, at least twenty-five (25) individual BFS vials. Other numbers of individual vials in a single BFS assembly are also possible according to one or more contemplated embodiments. In some embodiments, the array of individual vials 102a-102e can be simultaneously formed together during a BFS molding process, for example, using a rotary BFS molding machine. For example, a first portion 150 of the assembly 100 can initially be formed by a first pair of mold halves, a fluid can be injected into respective chambers in the formed first portion 150, and a second portion 152 of the assembly 100 can be formed by a subsequent pair of mold halves to seal the fluid within each respective BFS vial 102 (also referred to herein as a “BFS component” or “BFS bottle”). [0011] In some embodiments, each BFS vial 102 can comprise and/or define a vial neck 108 and a vial body 110. In the illustrated example of FIGS. 1 B-1 F, the vial body 110 of the BFS vial 102 can comprise and/or define a first chamber 122 (also referred to herein as a “dispensing reservoir”) proximal to a first longitudinal end 106 of the BFS vial 102, a second chamber 128 (also referred to herein as a “collapsible reservoir”) proximal to a second longitudinal end 104 of the BFS vial 102, and/or a distal tab region 126 (also referred to herein as a “label tab”, which may define an empty volume 138 or filled (e.g., solid) structure). In some embodiments, during the BFS molding process, an internal volume 130 of the second chamber 128 may be filled (fully or partially) with the fluid or other agent (not separately shown) to be delivered. In some embodiments, the second chamber 128 may be separated from the first chamber 122 by a constriction or narrowed portion 124, for example, as shown in FIGS. 1 E-1 F. In some embodiments, during the BFS molding process, one or more flange portions can be formed along the parting line, for example, extending laterally or radially from at least a portion of the vial body 110 (e.g., the first chamber). In the illustrated example, body flange 1 12 extends radially from the first chamber 122, the second chamber 128, and the label tab 126 of the BFS vial body 110. In some embodiments, the body flange 112 can serve as the connection between laterally-adjacent vials 102 within the molded assembly 100, for example, as shown in FIG. 1A. Alternatively or additionally, in some embodiments, adjacent BFS vials 102 within the molded assembly 100 can be connected together via removable flashing (not shown) between necks 108. In some embodiments, the flashing can be removed after molding, such that an open gap is between necks 108 of adjacent BFS vials 102 while the vials otherwise remain connected via body flanges 112, for example, as shown in FIG. 1A. [0012] In some embodiments, the vial neck 108 of the BFS vial 102 may comprise and/or define a top portion 136 (e.g., having or defining a fluid seal 114), a neck fore region 118, a neck aft region 120, and a mounting flange 116 (also referred to herein as a mounting collar) disposed between the fore and aft regions along the longitudinal axis 160. The vial neck 108 can define a neck internal volume 134 adjacent along longitudinal axis 160 to an internal volume 132 defined by the first chamber 122 (e.g., containing 1-mL or less of fluid). For example, the mounting flange 116 can define a “doughnut”-shaped or bulging disk exterior flange, as shown in FIGS. 1A-1 F. In some embodiments, for example, a diameter D2 of the mounting flange 116 can be greater than a diameter Di of a remaining portion of the neck 108 (e.g., the fore region 118 and/or the aft region 120), as shown in FIG. 1 E.

[0013] In some embodiments, the BFS assembly 100 may be coupled to an administration module or component with an interior volume or socket that comprises and/or defines (e.g., on or in an interior surface thereof) a shaped seat or hub configured to accept the mounting flange 116 of the BFS vial 102 (e.g., in the case that a first end 106 of the neck 108 of the BFS vial 102 is inserted into the socket). The mounting flange 116 may, for example, provide a radially elastic mating surface that is operable to provide a selective engagement or fit within the administration component socket. In some embodiments, the administration component and the BFS vial 102 may be coupled, e.g., in the field and/or in situ, for example, to provide an active pre-filled (e.g., injectable) medical delivery device. For example, the neck 108 of the BFS vial 102 may be urged and/or forced into the socket until the mounting flange 116 becomes seated in (and/or coupled to or mated with) a shaped seat (e.g., a seated position). Alternatively or additionally, in some embodiments, the administration component can engage with other portions of the BFS vial, for example, body flange 112. It should be noted that the subject matter disclosed herein is not dependent on any particular mating mechanism for engaging the BFS vial 102 with an administration module, nor any specific geometric configuration of the neck 108. Rather, embodiments of the disclosed subject matter are broadly applicable to any configuration of a BFS vial where a needle, cannula, or other tube is inserted through a fluid seal of the BFS vial to access and/or administer the fluid sealed therein.

[0014] In some embodiments, the administration component may comprise and/or house an internal cannula or needle, for example, for accessing contents of the BFS vial 102 by piercing a fluid seal 114 of a top portion 136 of the vial neck 108 when the BFS vial 102 is fully coupled to the administration component (e.g., when neck 108 is fully inserted into the socket of the administration component). In some embodiments, the administration component may comprise and/or support an external cannula or needle, for example, for piercing the skin of a patient to convey fluid from the BFS vial 102 into the patient. In some embodiments, the external needle may comprise a needle shaped and/or sized for at least one of subcutaneous, intramuscular, intradermal, and intravenous injection of fluid into the patient. Alternatively or additionally, the administration component may comprise or house a double-ended cannula or needle, for example, to pierce fluid seal 114 at one internal needle end when the vial neck 108 is inserted into the administration component and to pierce a patient’s skin at an opposite, external needle end. Alternatively or additionally, in some embodiments, the administration component may comprise and/or define an external nozzle (not shown) configured to control administration of the fluid to the patient. For example, the nozzle may be configured as a spray nozzle for administration of a fluid into the nasal passage, ear canal, or other orifice, or as a droplet nozzle for administration of a fluid into the eyes, topical administration, and the like.

[0015] Some embodiments may employ a modular design of separately constructed components cooperatively arranged and coupled to one another. For example, the BFS vial 102 and the administration component may be manufactured, packaged, shipped, stored, and/or provided as separate components. In such a manner, the administration component may not need to be stored or shipped in accordance with often restrictive requirements imposed on medicaments and may accordingly reduce the amount of space required for such specialized storage and/or shipping. The administration component may also or alternatively be manufactured, stored, and/or shipped in advance (e.g., at a first time) while the BFS vial 102 that is pre-filled with the fluid may be manufactured, stored, and/or shipped at a later time (e.g., a second time).

[0016] The fluid contained within the vial 102 may include any type of agent to be injected into a patient (e.g., human or non-human) and capable of producing an effect (alone, or in combination with an active ingredient). Accordingly, the fluid may include, but is not limited to, a medicament (e.g., a vaccine, a drug, a therapeutic agent, a diluent, an active ingredient, and/or any component of any of the foregoing). According to some embodiments, the contents of the vial 102 may be tracked, monitored, checked for compatibility, etc., such as by utilization of electronic data storage devices (not shown) coupled to one or more of the various components, such as label tab 126 of BFS vial 102 and/or the administration component.

[0017] In some embodiments, such as in the case that the entire BFS vial 102 has a length (e.g., as measured along the longitudinal direction, L) in a range of 60-mm to 80-mm, inclusive (for example, approximately 70-mm), the diameter D2 (e.g., as measured along the radial direction, R) of the neck 108 may be in a range of 6.5-mm to 7.8-mm, inclusive (for example, approximately 7.3-mm). According to some embodiments, the diameter of the neck 108 may vary, such as having different diameters below the mounting flange 116 and above the mounting flange 116. Alternatively, in some embodiments, the mounting flange 116 (or at least the protruding portion thereof) can be omitted, such that neck 108 has a substantially constant diameter along its length (e.g., from top portion 136 to the first chamber 122 and/or body flange 112).

[0018] In some embodiments, the overall length (e.g., as measured along the longitudinal direction, L) of the neck 108 may be in a range of 10-mm to 11 -mm, inclusive (for example, approximately 10.44-mm). In some embodiments, the mounting flange 116 may be centered along the length of the neck 108 (e.g., along the longitudinal direction, L). In some embodiments, the length (e.g., as measured along the longitudinal direction, L) of the mounting flange 116 may be in a range of 3-mm to 4-mm, inclusive (for example, approximately 3.45-mm). In some embodiments, a length (e.g., as measured along the longitudinal direction, L) of the neck aft region 120 may be approximately 3.38-mm, a length (e.g., as measured along the longitudinal direction, L) of the neck fore region 118 may be approximately 2.52-mm, and/or a length (e.g., as measured along the longitudinal direction, L) of the top portion 136 may be approximately 1-mm.

[0019] In some embodiments, fewer or more components and/or various configurations of the depicted components may be included in the BFS assembly 100 without deviating from the scope of embodiments described herein. Further details regarding configurations and uses of BFS vials can be found in International Publication No. WO 2021/207040, published October 14, 2021 and entitled “Systems and Methods for Pre-Filled Medical Delivery Devices,” which is incorporated by reference herein in its entirety.

[0020] In some embodiments, fluid seal 114 can be formed by a portion of the BFS vial 102, for example, as a portion of the vial wall disposed at a first end 106 where a parting plane (also referred to herein as a “parting line” that extends around the circumference of the object to define molded halves) defined by the BFS molding process and the longitudinal axis 160 intersect. For example, the BFS molding process can define a wall thickness (e.g., as measured along longitudinal axis 160) of the top portion 136 of the neck 108, which wall thickness can in turn define the fluid seal 114. Since the fluid seal 114 is located on the weld joint between the molded vial halves, piercing of the seal 114 to dispense fluid from the vial 102 may weaken the junction between molded halves of the vial 102, which may increase a chance of leakage around the pierced portion of the fluid seal 114. Accordingly, in some embodiments, the molding process can be modified to increase the thickness of the fluid seal 114, for example, as compared to wall thickness ti (e.g., as measured along a radial direction, R, for example, in a direction perpendicular to, or at least crossing, the parting plane). For example, in some embodiments, the wall thickness at the fluid seal 114 can be at least 10% greater than the wall thickness ti away from the fluid seal 114 (e.g., 1.1 x ti). In some embodiments, as described in further detail hereinbelow, portions of the rotary BFS mold used to form the BFS vial 102 can be adapted to increase the thickness of the fluid seal 114, thereby strengthening the fluid seal 114 of the BFS vial 102 during piercing by an administration component and/or subsequent fluid injection into the patient.

III. BFS Molding Systems

[0021] FIGS. 2A-2B illustrate an exemplary rotary BFS machine 200 that can be used to form a BFS assembly 100 with strengthened fluid seals. As used herein, the term “rotary” with respect to BFS manufacturing and BFS manufacturing machines and processes refers to BFS machines and processes in which the parison remains continuous (e.g., is not cut) between cycles/product “cards.” There are two primary types of rotary BFS machines: (i) carousel machines, such as the Bottelpack™ bp460 machine (from Rommelag Kunststoff-Maschinen Vertriebsgesellschaft mbH of Waiblingen, Germany), which utilize counter-rotating chains of cooperative mold halves and (ii) hybrid machines, such as the Bottelpack™ bp434 machine (from Rommelag Kunststoff-Maschinen Vertriebsgesellschaft mbH of Waiblingen, Germany), which utilize a single set of cooperative mold halves. In some embodiments, the rotary BFS machine 200 may comprise either a carousel-style machine or a hybrid-style machine. For ease of illustration herein, the rotary BFS machine 200 is depicted and described as a carousel-style rotary BFS machine/process.

[0022] The rotary BFS machine 200 may comprise, for example, a rotary BFS mold system that is configured to dynamically rearrange (e.g., in a rotary manner) a plurality of corresponding mold halves 204. While not explicitly detailed in FIGS. 2A-2B, in some embodiments, each respective set of mold halves 204a, 204b may be configured to form a primary portion of desired BFS vials (such as a fluid reservoir structure, e.g., chambers 122 and/or 128 in FIGS. 1A-1 F) and a secondary portion of the BFS vials (such as a neck and/or seal thereof, e.g., neck 108 and fluid seal 114 in FIGS. 1A-1 F), for example, in a rotational sequence. In the illustrated example of FIG. 2A, the rotary BFS machine 200 has a pair of opposing tracks 202a, 202b. Track 202a can comprise a plurality of carrying members 208a (also referred to herein as “mold holders”) supporting first mold halves 204a via respective lateral actuators 206a. While the term “carrying member” is utilized for convenience and ease of illustration, in some embodiments, the carrying member 208 may comprise only a mold half and/or a combined mold half and mold holder (e.g., with elements of what would typically be a holder and a mold half jointly incorporated therein - e.g., a unibody or integral design).

[0023] Track 202a can also comprise one or more rotary members or hubs 218a, 220a that rotate the carrying members 208a in a clockwise direction. Similarly, track 202b can comprise a plurality of carrying members 208b supporting second mold halves 204b via respective lateral actuators 206b. Track 202b can also comprise one or more rotary members or hubs 218b, 220b that rotate the carrying members 208b in a counter-clockwise direction. In some embodiments, each first mold half 204a can be substantially identical to (e.g., reflection symmetric with respect to) a corresponding one of the second mold halves 204b. In some embodiments, each mold half 204a, 204b can be as illustrated in FIGS. 3A-3G, as described in further detail below. According to some embodiments, respective mold halves 204a, 204b may engage with a product stream such as parison portions 212a, 212b (e.g., opposite portions of a tube of molten plastic) to form a BFS assembly. In some embodiments, the parison portions can be extruded and/or formed by a parison system (not shown) of the BFS system. For example, in operation during the BFS molding process, an upper portion of a pair of mold halves 204a, 204b from the opposing tracks 202a, 202b approach each other and are extended via lateral actuator 206a, 206b at a first stage 214 of the machine 200 so as to clamp parison portions 212a, 212b between facings surfaces 222a, 222b of the mold halves 204a, 204b, thereby molding a first portion 150 of the BFS assembly 100.

[0024] In some embodiments, the BFS system may comprise a product source, such as a fluid product reservoir that provides a fill product (e.g., fluid, such as a medicament). A fluid injector 210 (e.g., a filling mandrel array, such as a plurality of filling needles or mandrels) coupled to the product source can then dispense a predetermined volume of fluid (e.g., 1-mL or less, such as approximately 0.6-mL) into the formed first portion 150. After the fluid dispensing, a lower portion of a subsequent pair of mold halves 204a, 204b from the opposing tracks 202a, 202b approach each other and are extended via lateral actuators 206a, 206b at a second stage 216 of the machine 200 so as to further clamp parison portions 212a, 212b between facings surfaces 222a, 222b, thereby molding a second portion 152 of the assembly 100 and sealing the fluid within each vial 102. A molded assembly 100 is thus produced between two successive pairs of mold halves 204 of the machine 200, as indicated, for example, at 224.

[0025] Fewer or more components 202-222 and/or various configurations of the depicted components 202-222 may be included in the rotary BFS machine 200 without deviating from the scope of embodiments described herein. For example, in some embodiments, a BFS machine and/or BFS system can further include a mold cooling device or features operable to provide cooling (e.g., remove heat from) the BFS machine and/or the mold halves thereof. [0026] While the BFS manufacturing process is commonly referred to as “Blow-Fill-Seal,” for example, BFS product processes may utilize blown air and/or vacuum to engage the parison with the cavities (not separately shown) of the cooperative mold halves 204. Thus, in some embodiments, the BFS machine and/or BFS system can include a vacuum device (e.g., a vacuum pump, vacuum tubes, fittings, hoses, and/or connections that are coupled to selectively apply vacuum force to the mold halves or portions thereof, for example, to draw the parison into cavities of the mold) and/or a pressurized air supply (e.g., air pump, air tubes, fittings, hoses, and/or connections that are coupled to selectively apply pressurized to the mold halves or portions thereof). Further details regarding vacuum operation of a rotary BFS machine can be found in International Application No. PCT/US22/21752, filed March 24, 2022 and entitled “Systems and Methods for Rotary Blow-Fill-Seal (BFS) Machine Staged Vacuum,” which is incorporated herein by reference. In some embodiments, the rotary BFS machine 200 (and/or portion thereof) may comprise a carousel or hybrid rotary style BFS machine, system, and/or platform programmed and/or otherwise configured to execute (e.g., via a computerized controller device; not shown), conduct, and/or facilitate methods described herein.

IV. BFS Molds

[0027] In some embodiments, the features of each mold half can be designed to urge molten plastic toward the parting line at an end of each BFS vial, for example, to thicken a wall at an end of the neck that defines the fluid seal. For example, FIGS. 3A-3G illustrate features of an exemplary mold half 204 that can be used (e.g., in a rotary BFS machine) to mold BFS vials with modified fluid seals, such as the BFS vials of FIGS. 1 A-1 F. Referring initially to FIG. 3A, the mold half 204 can have a surface 300 with one or more protruding or recessed structures that define at least a first pattern 306a proximal to a top end 304 of the mold half 204 and a second pattern 306b proximal to a bottom end 302 of the mold half 204. When the surfaces 300 of a first pair of opposing mold halves 204 are brought together during the BFS molding process, the first pattern 306a can be constructed to form the first portion 150 of the BFS assembly 100, for example, at least the neck 108, the first chamber 122, and part of the second chamber 128. For example, as shown in FIG. 3F, the first pattern of the mold half can have a first cavity portion 308a constructed to form the top portion 136 of the vial neck 108, a second cavity portion 308b constructed to form the neck fore region 118, a third cavity portion 308c constructed to form mounting flange 116, a fourth cavity region 308d constructed to form neck aft region 120, and/or a fifth cavity region 308e constructed to form at least part of first chamber 122. When the surfaces 300 of a subsequent pair of opposing mold halves 204 are brought together during the BFS molding process, the second pattern 306b can be constructed to form the second portion 152 of the assembly 100, for example, to seal the second chamber 128 and form the label tab 126. The facing surfaces 300 of the mold halves 204 can define a parting plane and therefore a weld joint between molded halves of the BFS vial.

[0028] In some embodiments, at least the first pattern 306a of the mold half 204 can include modifications to pinchline and/or dam surface portions so as to increase a wall thickness of the weld joint, for example, without otherwise increasing external dimensions of the resulting vial neck 108. For example, a depth of the dam surface (e.g., as measured from the pinchline or a surface of the mold) can be based on the thickness of the plastic (e.g., a thickness of the parison and/or a wall thickness (e.g., fe) of the formed BFS vial), for example, approximately 40- 60% of the plastic thickness. Alternatively or additionally, in some embodiments, a pinch angle (e.g., an angle of the sloped surface extending between the pinchline and the dam surface) in the first pattern 306a can be based on the type of plastic. For example, when molding low-density polyethylene (LDPE), the pinch angle may be in a range of 20-45°, inclusive, while when molding polypropylene (PP), the pinch angle may be sharper.

[0029] Referring to FIGS. 3B-3G, portions of a first pattern 306a of an exemplary mold half 204 are shown in detail. A pinch surface portion 310 (also referred to herein as “pinchline”) can surround cavity 308 and can come into contact with the pinch surface portion 310 of an opposing mold half during molding to define separate vials of the assembly 100. A recessed dam surface portion 314 can be disposed on a side of the pinch surface portion 310 opposite from the cavity 308. A first angled surface portion 312 (e.g., at an angle, I, with respect to a direction perpendicular to the parting plane) can connect the dam surface portion 314 to the pinch surface portion 310. A further recessed relief surface portion 318 (e.g., a depth, E, in a range of 0.8-mm to 1 ,5-mm, inclusive, for example, in a range of 0.9-mm to 1.1 -mm, inclusive) can be disposed on a side of the dam surface portion 314 opposite from the pinch surface portion 310. A second angled surface portion 316 (e.g., at an angle, J, with respect to a direction perpendicular to the parting plane) can connect the relief surface portion 318 to the dam surface portion 314. A further recessed landing surface portion 322 can be disposed on a side of the relief surface portion 318 opposite from the dam surface portion 314. A third angled surface portion 320 (e.g., at an angle, K, with respect to a direction perpendicular to the parting plane) can connect the landing surface portion 322 to the relief surface portion 318. Alternatively, in some embodiments, the relief surface portion 318 can be omitted (e.g., depth E = depth F in FIG. 3G), such that recessed landing surface portion 322 directly connects to the dam surface portion 314 via a new angled surface. Between dam surface portions 314 to define necks of adjacent vials, a further recessed neck landing surface portion 324 can be disposed (e.g., at a depth less than the dam surface portion 314 and relief surface portion 318). Exemplary values for dimensions defining the different surface portions in FIGS. 3B and 3G are shown in Table 1 below.

Table 1 : Exemplary ranges and values for surface portions defining part of BFS mold first pattern (FIGS. 3B, 3G).

[0030] FIGS. 4A-4B show detailed portions of a prior mold pattern with a pinch surface 410, a dam surface portion 414 connected to the pinch surface 410 by a first angled surface portion 412, and a landing surface portion 418 connected to the dam surface portion 414 by a second angled surface portion 416. As compared to the prior mold pattern of FIGS. 4A-4B, a lateral size of the dam surface portion can be increased (e.g., wider dam surface portion 314 in FIGS. 3D-3E versus narrower dam surface portion 414 in FIGS. 4A-4B), a depth of the dam surface portion (e.g., as measured from the pinchline) can be decreased (e.g., shallower dam surface portion 314 in FIGS. 3D-3E versus deeper dam surface portion 414 in FIGS. 4A-4B), and/or one or more additional recessed surface portions can be provided (e.g., surface portions 318, 322, and 324 in FIGS. 3D-3E versus only landing surface portion 418 in FIGS. 4A-4B).

V. BFS Fabrication Methods

[0031] FIG. 5 shows an exemplary method 500 for simultaneously fabricating an assembly of filled BFS vials filled having modified fluid seals using a rotary BFS machine. The method 500 can initiate at process block 502, where a plurality of paired BFS mold halves are installed in a rotary BFS molding machine, such as BFS machine 200 described with respect to FIGS. 2A-2B above. For example, each BFS mold half can have the same structure and molding function as mold half 204 described with respect to FIGS. 3A-3G above. The method 500 can proceed to process block 504, where a first pair of opposing BFS mold halves in the rotary BFS machine can be used to form a first portion of each BFS vial. In some embodiments, the formed first portion can define at least a first chamber of each BFS vial. In some embodiments, the formed first portion can also define the modified fluid seal of each BFS vial. For example, the formed first portion can have the same structure and function as first portion 150 of the vial assembly 100 described with respect to FIGS. 1A-1 D above.

[0032] The method 500 can proceed to process block 506, where at least a portion of the formed first portion of each BFS vial can be filled by the rotary BFS machine with a predetermined volume (e.g., < 1-mL, such as approximately 0.6-mL) of fluid (e.g., medicament). The method 500 can then proceed to process block 508, where a second pair of opposing BFS mold halves in the rotary BFS machine can be used to form a second portion of each BFS vial. In some embodiments, the formed second portion can seal at least the first chamber of each BFS vial with the dispensed fluid retained therein. For example, the formed second portion can have the same structure and function as second portion 152 of the vial assembly 100 described with respect to FIGS. 1A-1 D above.

[0033] In some embodiments, the method 500 can proceed to process block 510, where the formed BFS vials are separated from surrounding material. For example, excess plastic trim or flashing surrounding the assembly and/or portions of individual vials in the assembly can be removed (e.g., punching or other machining techniques). For example, in some embodiments, the flashing between necks of adjacent BFS vials can be removed while the adjacent BFS vials otherwise remain connected together via their respective body flanges. Alternatively or additionally, in some embodiments, the assembly can be separated into sub-assemblies, for example, five- container cards from an assembly of twenty-five (25) vials. In some embodiments, the method 500 can proceed to process block 512, where one or more BFS vials are prepared to administer the filled fluid (e.g., medicament) to a patient. For example, the preparation can involve coupling an administration component to the neck 108, such that an internal needle of the administration component pierces fluid seal 114. Since the fluid seal has been strengthened by the molding process, leakage around the needle piercing the fluid seal and/or through the parting line of the BFS vial can be avoided or at least reduced.

[0034] Although some of blocks 502-512 of method 500 have been described as being performed once, in some embodiments, multiple repetitions of a particular process block may be employed before proceeding to the next decision block or process block. In addition, although blocks 502-512 of method 500 have been separately illustrated and described, in some embodiments, process blocks may be combined and performed together (simultaneously or sequentially) or performed in an overlapping manner (e.g., such that filling of process block 506 begins before the molding of process block 504 is completed). Moreover, although FIG. 5 illustrates a particular order for blocks 502-512, embodiments of the disclosed subject matter are not limited thereto. Indeed, in certain embodiments, the blocks may occur in a different order than illustrated or simultaneously with other blocks.

VI. Additional Examples of the Disclosed Technology

[0035] In view of the above described implementations of the disclosed subject matter, this application discloses the additional examples in the clauses enumerated below. It should be noted that one feature of a clause in isolation, or more than one feature of the clause taken in combination, and, optionally, in combination with one or more features of one or more further clauses are further examples also falling within the disclosure of this application.

[0036] Clause 1 . A blow-fill-seal (BFS) assembly comprising: at least one BFS vial, each BFS vial comprising: a first chamber containing a fluid therein; and a neck portion in fluid communication with the first chamber, wherein the BFS vial has a first end and a second end along a longitudinal direction, the first chamber being disposed between the second end and the neck portion along the longitudinal direction, the neck portion has a first wall at the first end of the BFS vial that defines a fluid seal, the BFS vial has a parting line defined by a first plane parallel to the longitudinal direction, the first wall defining the fluid seal has, at the parting line, a first thickness along the longitudinal direction, the first chamber is defined by a second wall extending along the longitudinal direction, the second wall having a second thickness along a radial direction perpendicular to the longitudinal direction, and the first thickness is greater than the second thickness.

[0037] Clause 2. The BFS assembly of any clause or example herein, in particular, Clause 1 , wherein the first thickness is equal to or greater than 1 .1 times the second thickness.

[0038] Clause 3. The BFS assembly of any clause or example herein, in particular, any one of Clauses 1- 2, wherein the second thickness is along a direction substantially perpendicular to the first plane. [0039] Clause 4. The BFS assembly of any clause or example herein, in particular, any one of Clauses 1- 3, further comprising (i) a second chamber disposed between the second end and the first chamber, or (ii) a second chamber disposed between the neck portion and the first chamber.

[0040] Clause 5. The BFS assembly of any clause or example herein, in particular, Clause 4, wherein the first and second chambers are separated from each other by a constriction.

[0041] Clause 6. The BFS assembly of any clause or example herein, in particular, any one of Clauses 1- 5, wherein the BFS assembly is formed of a plastic.

[0042] Clause 7. The BFS assembly of any clause or example herein, in particular, Clause 6, wherein the plastic comprises polyethylene or polypropylene.

[0043] Clause 8. The BFS assembly of any clause or example herein, in particular, any one of Clauses 1-

7, wherein the fluid seal of each BFS vial is constructed for penetration by a needle of a respective administration assembly when the administration assembly is coupled to the neck portion of the BFS vial, so as to provide a leak- free fluid path from the first chamber to a dispensing or administration end of the needle that is outside the BFS vial.

[0044] Clause 9. The BFS assembly of any clause or example herein, in particular, any one of Clauses 1-

8, wherein a volume of fluid in each first chamber is less than 1-mL.

[0045] Clause 10. The BFS assembly of any clause or example herein, in particular, any one of Clauses 1-

9, wherein the fluid in each first chamber comprises a medicament.

[0046] Clause 11 . The BFS assembly of any clause or example herein, in particular, any one of Clauses 1 -

10, wherein each BFS vial further comprises one or more flange portions extending radially outward from the first chamber along the first plane.

[0047] Clause 12. The BFS assembly of any clause or example herein, in particular, Clause 11 , wherein the at least one BFS vial is a plurality of BFS vials arranged in an array, with facing flange portions connecting adjacent BFS vials together.

[0048] Clause 13. The BFS assembly of any clause or example herein, in particular, any one of Clauses 1-

12, wherein the at least one BFS vial is at least five BFS vials.

[0049] Clause 14. The BFS assembly of any clause or example herein, in particular, any one of Clauses 1-

13, wherein the at least one BFS vial is at least twenty-five BFS vials. [0050] Clause 15. The BFS assembly of any clause or example herein, in particular, any one of Clauses 12- 14, wherein the neck portion of each BFS vial is separated from the neck portion of an adjacent BFS vial in the array by an open gap.

[0051] Clause 16. A mold for fabricating a blow-fill-seal (BFS) assembly using a rotary BFS machine, the BFS assembly comprising at least one BFS vial, the mold comprising: a first mold half with a first mold pattern; and a second mold half with a second mold pattern, the second mold pattern being a mirror image of the first mold pattern, wherein each of the first and second mold patterns has a first pattern portion constructed to define a neck portion and a first chamber of each BFS vial, the first pattern portion comprises, for each BFS vial:

(i) a first recess for forming at least part of the first chamber;

(ii) a second recess for forming the neck portion;

(iii) a pinch surface disposed at and substantially parallel to a contact plane of the respective mold half and bounding at least a portion of the second recess;

(iv) a dam surface disposed on a side of the pinch surface opposite from the second recess and connected to the pinch surface via a first angled surface, the dam surface being substantially parallel to the contact plane and spaced from the contact plane by a first distance; and

(v) a relief surface disposed on a side of the dam surface opposite from the pinch surface and connected to the dam surface via a second angled surface, the relief surface being substantially parallel to the contact plane and spaced from the contact plane by a second distance greater than the first distance, and at least the pinch and dam surfaces are arranged to urge portions of molten plastic toward the pinch surfaces of the first and second mold halves during molding in the rotary BFS machine so as to thicken a wall of the BFS vial at a part of the neck portion along a parting line between the mold halves.

[0052] Clause 17. The mold of any clause or example herein, in particular, Clause 16, wherein the first distance is in a range of 40% to 60%, inclusive, of a thickness of the plastic.

[0053] Clause 18. The mold of any clause or example herein, in particular, any one of Clauses 16-17, wherein the first angled surface is at a first angle with respect to a direction perpendicular to the contact plane, and the first angle is in a range of 30-45°, inclusive.

[0054] Clause 19. The mold of any clause or example herein, in particular, any one of Clauses 16-18, wherein the second distance is in a range of 0.9-mm to 1 ,5-mm, inclusive. [0055] Clause 20. The mold of any clause or example herein, in particular, any one of Clauses 16-19, wherein the second angled surface is at a second angle with respect to a direction perpendicular to the contact plane, and the second angle is in a range of 10-20°, inclusive.

[0056] Clause 21. The mold of any clause or example herein, in particular, any one of Clauses 16-20, wherein: the first angled surface is at a first angle with respect to a direction perpendicular to the contact plane; the second angled surface is at a second angle with respect to the direction perpendicular to the contact plane; and the first angle is greater than the second angle.

[0057] Clause 22. The mold of any clause or example herein, in particular, any one of Clauses 16-21 , wherein: a thickness of the plastic is less than or equal to 1-mm; the first distance is about 0.5-mm; the second distance is in a range of 0.8-mm to 1.1 -mm, inclusive; or any combination of the above.

[0058] Clause 23. The mold of any clause or example herein, in particular, any one of Clauses 16-22, wherein the first pattern portion further comprises a landing surface disposed on a side of the relief surface opposite from the dam surface and connected to the relief surface via a third angled surface, the landing surface being substantially parallel to the contact plane and spaced from the contact plane by a third distance greater than the second distance.

[0059] Clause 24. The mold of any clause or example herein, in particular, Clause 23, wherein the third distance is greater than or equal to 100% of a thickness of the plastic.

[0060] Clause 25. The mold of any clause or example herein, in particular, any one of Clauses 23-24, wherein the third angled surface is at a third angle with respect to a direction perpendicular to the contact plane, and the third angle is in a range of 30-45°, inclusive.

[0061] Clause 26. The mold of any clause or example herein, in particular, any one of Clauses 16-25, wherein a depth of the second recess with respect to the contact plane is in a range of 3-mm to 3.9-mm, inclusive.

[0062] Clause 27. The mold of any clause or example herein, in particular, any one of Clauses 16-26, wherein each of the first and second mold patterns has a second pattern portion constructed to seal the first chamber of each BFS vial in a previously formed BFS assembly, the second pattern portion being disposed on an opposite side of the respective mold half from the first pattern portion. [0063] Clause 28. The mold of any clause or example herein, in particular, any one of Clauses 16-27, wherein the first pattern portion is constructed to simultaneously define the neck portion and the first chamber for at least five BFS vials or for at least twenty-five BFS vials.

[0064] Clause 29. The mold of any clause or example herein, in particular, any one of Clauses 16-28, wherein the first pattern portion is constructed to further define, for each BFS vial, one or more flange portions extending radially outward from the respective first chamber.

[0065] Clause 30. A blow-fill-seal (BFS) machine comprising the mold according to any clause or example herein, in particular, any one of Clauses 16-29.

[0066] Clause 31 . A method for fabricating a blow-fill-seal (BFS) assembly comprising at least one BFS vial, the method comprising:

(a) providing a plurality of molds in a rotary BFS machine, each mold comprising a first mold half with a first mold pattern a second mold half with a second mold pattern, the first mold pattern being a mirror image of the second mold pattern, each of the first and second mold patterns having a first pattern portion constructed to define a neck portion and a first chamber of each BFS vial, wherein the first pattern portion comprises, for each BFS vial:

(i) a first recess for forming at least part of the first chamber;

(ii) a second recess for forming the neck portion;

(v) a relief surface disposed on a side of the dam surface opposite from the pinch surface and connected to the dam surface via a second angled surface, the relief surface being substantially parallel to the contact plane and spaced from the contact plane by a second distance greater than the first distance;

(b) after (a), molding, using a first mold of the plurality of molds in the rotary BFS machine, molten plastic to form the neck portion and the first chamber of each BFS vial of the BFS assembly, wherein at least the pinch and dam surfaces urge portions of the molten plastic toward the pinch surfaces of the first and second mold halves so as to thicken a wall of the BFS vial at a part of the neck portion along a parting line between the mold halves;

(c) after (b), filling the first chamber of each BFS vial with a respective fluid; and

(d) after (c), sealing, using a second mold of the plurality of molds in the rotary BFS machine, the first chamber of BFS vial with the fluid therein. [0067] Clause 32. The method of any clause or example herein, in particular, Clause 31 , wherein, after (b): each BFS vial has a first end and a second end along a longitudinal direction, the first chamber being disposed between the second end and the neck portion along the longitudinal direction, the neck portion has a first wall at the first end of the BFS vial that defines a fluid seal, the first wall defining the fluid seal has, at the parting line, a first thickness along the longitudinal direction, the first chamber is defined by a second wall extending along the longitudinal direction, the second wall having a second thickness along a radial direction perpendicular to the longitudinal direction, and the first thickness is greater than the second thickness.

[0068] Clause 33. The method of any clause or example herein, in particular, Clause 32, wherein the first thickness is equal to or greater than 1.1 times the second thickness.

[0069] Clause 34. The method of any clause or example herein, in particular, any one of Clauses 32-33, wherein the second thickness is along a direction substantially perpendicular to the first plane.

[0070] Clause 35. The method of any clause or example herein, in particular, any one of Clauses 31-34, wherein the plastic comprises polyethylene or polypropylene.

[0071] Clause 36. The method of any clause or example herein, in particular, any one of Clauses 31-35, wherein, after (c), a volume of fluid filled in each first chamber is less than 1-mL.

[0072] Clause 37. The method of any clause or example herein, in particular, any one of Clauses 31-36, wherein the fluid filled in (c) comprises a medicament.

[0073] Clause 38. The method of any clause or example herein, in particular, any one of Clauses 31-37, wherein the molding of (b) is such that one or more flange portions are formed that extend radially outward from the first chamber of each BFS vial.

[0074] Clause 39. The method of any clause or example herein, in particular, any one of Clauses 31-38, wherein the at least one BFS vial is a plurality of BFS vials arranged in an array with facing flange portions connecting adjacent BFS vials together.

[0075] Clause 40. The method of any clause or example herein, in particular, any one of Clauses 31-39, wherein (b)-(d) are such that at least five BFS vials, or at least twenty-five BFS vials, are simultaneously formed for the BFS assembly.

[0076] Clause 41. The method of any clause or example herein, in particular, any one of Clauses 31-40, wherein, after (d), the neck portion of each BFS vial is separated from the neck portion of an adjacent BFS vial in the array by removable flashing. [0077] Clause 42. A BFS assembly fabricated by the method of any clause or example herein, in particular, any one of Clauses 31-41.

VII. Rules of Interpretation

[0078] Any or all of the BFS components disclosed herein can be formed of one or more plastics. In some embodiments, some components (e.g., the BFS vials) can be formed of a relatively soft polymer (e.g., having a Shore/Durometer “D” hardness of between 60 and 70), such as polyethylene (e.g., low density polyethylene (LDPE)), polypropylene, or any other polymer adaptable for use in a BFS manufacturing process. In some embodiments, some components (e.g., the connection assemblies, the administration assemblies, and/or needle caps or covers) can be formed, at least in part, of a relatively hard polymer (e.g., having a hardness greater than 80 on the Rockwell “R” scale), such as, but not limited to, polypropylene, polycarbonate, polybenzimidazole, acrylonitrile butadiene styrene (ABS), polystyrene, polyvinyl chloride, or the like. Other materials are also possible according to one or more contemplated embodiments. Any or all of the BFS molding machine components disclosed herein, for example, each BFS mold half can be formed of one or more metals. In some embodiments, each BFS mold half can comprise steel. Other materials are also possible according to one or more contemplated embodiments.

[0079] Throughout the description herein and unless otherwise specified, the following terms may include and/or encompass the example meanings provided. These terms and illustrative example meanings are provided to clarify the language selected to describe embodiments both in the specification and in the appended claims, and accordingly, are not intended to be generally limiting. While not generally limiting and while not limiting for all described embodiments, in some embodiments, the terms are specifically limited to the example definitions and/or examples provided. Other terms are defined throughout the present description.

[0080] Numerous embodiments are described in this patent application, and are presented for illustrative purposes only. The described embodiments are not, and are not intended to be, limiting in any sense. The presently disclosed invention(s) are widely applicable to numerous embodiments, as is readily apparent from the disclosure. One of ordinary skill in the art will recognize that the disclosed invention(s) may be practiced with various modifications and alterations, such as structural, logical, software, and electrical modifications. Although particular features of the disclosed invention(s) may be described with reference to one or more particular embodiments and/or drawings, it should be understood that such features are not limited to usage in the one or more particular embodiments or drawings with reference to which they are described, unless expressly specified otherwise.

[0081] The present disclosure is neither a literal description of all embodiments of the invention nor a listing of features of the invention that must be present in all embodiments. [0082] Neither the Title (set forth at the beginning of the first page of this patent application) nor the Abstract (set forth at the end of this patent application) is to be taken as limiting in any way as the scope of the disclosed invention(s).

[0083] While the terms “vial” and “container” have been utilized herein for convenience and ease of illustration, objects represented and/or described as “vials” or “containers” may comprise various forms, configurations, and/or quantities of components. A BFS vial may comprise one or more BFS products that are formed and/or manufactured together or separately, for example, and/or may comprise one or more BFS chambers, bottles, vials, modules, and/or other fluid-retaining objects. The term “vial” or “container” does not convey any designation of shape or size. In some embodiments, a BFS component may comprise one or more vials. According to some embodiments, a BFS component and/or a BFS vial may comprise one or more fluid chambers. In some embodiments, a plurality of BFS vials, containers, and/or chambers may be manufactured simultaneously from a single BFS mold. Each respective container and/or chamber may be formed, for example, by different portions of a single BFS mold (e.g., two cooperative halves thereof). In some embodiments, BFS components, vials, and/or chambers may be joined and/or coupled during manufacturing (e.g., via unformed and/or fused connecting parison) and/or after manufacturing/filling.

[0084] The term "product" means any machine, manufacture and/or composition of matter as contemplated by 35 U.S.C. §101 , unless expressly specified otherwise.

[0085] The terms "an embodiment", "embodiment", "embodiments", "the embodiment", "the embodiments", "one or more embodiments", "some embodiments", "one embodiment" and the like mean "one or more (but not all) disclosed embodiments", unless expressly specified otherwise.

[0086] A reference to "another embodiment" in describing an embodiment does not imply that the referenced embodiment is mutually exclusive with another embodiment (e.g., an embodiment described before the referenced embodiment), unless expressly specified otherwise.

[0087] The terms "a", "an" and "the" mean "one or more", unless expressly specified otherwise.

[0088] The term "plurality" means "two or more", unless expressly specified otherwise.

[0089] The term "herein" means "in the present application, including anything which may be incorporated by reference", unless expressly specified otherwise.

[0090] The phrase "at least one of", when such phrase modifies a plurality of things (such as an enumerated list of things) means any combination of one or more of those things, unless expressly specified otherwise. For example, the phrase at least one of a widget, a car and a wheel means either (i) a widget, (ii) a car, (iii) a wheel, (iv) a widget and a car, (v) a widget and a wheel, (vi) a car and a wheel, or (vii) a widget, a car and a wheel.

[0091] The phrase "based on" does not mean "based only on", unless expressly specified otherwise. In other words, the phrase "based on" describes both "based only on" and "based at least on". [0092] Where a limitation of a first claim would cover one of a feature as well as more than one of a feature (e.g., a limitation such as "at least one widget" covers one widget as well as more than one widget), and where in a second claim that depends on the first claim, the second claim uses a definite article "the" to refer to the limitation (e.g., "the widget"), this does not imply that the first claim covers only one of the feature, and this does not imply that the second claim covers only one of the feature (e.g., "the widget" can cover both one widget and more than one widget).

[0093] Each process (whether called a method, algorithm or otherwise) inherently includes one or more steps, and therefore all references to a "step" or "steps" of a process have an inherent antecedent basis in the mere recitation of the term 'process' or a like term. Accordingly, any reference in a claim to a 'step' or 'steps' of a process has sufficient antecedent basis.

[0094] When an ordinal number (such as "first", "second", "third" and so on) is used as an adjective before a term, that ordinal number is used (unless expressly specified otherwise) merely to indicate a particular feature, such as to distinguish that particular feature from another feature that is described by the same term or by a similar term. For example, a "first widget" may be so named merely to distinguish it from, e.g., a "second widget". Thus, the mere usage of the ordinal numbers "first" and "second" before the term "widget" does not indicate any other relationship between the two widgets, and likewise does not indicate any other characteristics of either or both widgets. For example, the mere usage of the ordinal numbers "first" and "second" before the term "widget" (1) does not indicate that either widget comes before or after any other in order or location; (2) does not indicate that either widget occurs or acts before or after any other in time; and (3) does not indicate that either widget ranks above or below any other, as in importance or quality. In addition, the mere usage of ordinal numbers does not define a numerical limit to the features identified with the ordinal numbers. For example, the mere usage of the ordinal numbers "first" and "second" before the term "widget" does not indicate that there must be no more than two widgets.

[0095] When a single device or article is described herein, more than one device or article (whether or not they cooperate) may alternatively be used in place of the single device or article that is described. Accordingly, the functionality that is described as being possessed by a device may alternatively be possessed by more than one device or article (whether or not they cooperate).

[0096] Similarly, where more than one device or article is described herein (whether or not they cooperate), a single device or article may alternatively be used in place of the more than one device or article that is described. For example, a plurality of computer-based devices may be substituted with a single computer-based device. Accordingly, the various functionality that is described as being possessed by more than one device or article may alternatively be possessed by a single device or article.

[0097] The functionality and/or the features of a single device that is described may be alternatively embodied by one or more other devices which are described but are not explicitly described as having such functionality and/or features. Thus, other embodiments need not include the described device itself, but rather can include the one or more other devices which would, in those other embodiments, have such functionality / features.

[0098] Devices that are in communication with each other need not be in continuous communication with each other, unless expressly specified otherwise. On the contrary, such devices need only transmit to each other as necessary or desirable, and may actually refrain from exchanging data most of the time. For example, a machine in communication with another machine via the Internet may not transmit data to the other machine for weeks at a time. In addition, devices that are in communication with each other may communicate directly or indirectly through one or more intermediaries.

[0099] A description of an embodiment with several components or features does not imply that all or even any of such components and/or features are required. On the contrary, a variety of optional components are described to illustrate the wide variety of possible embodiments of the present invention(s). Unless otherwise specified explicitly, no component and/or feature is essential or required.

[0100] Further, although process steps, algorithms or the like may be described in a sequential order, such processes may be configured to work in different orders. In other words, any sequence or order of steps that may be explicitly described does not necessarily indicate a requirement that the steps be performed in that order. The steps of processes described herein may be performed in any order practical. Further, some steps may be performed simultaneously despite being described or implied as occurring non-simultaneously (e.g., because one step is described after the other step). Moreover, the illustration of a process by its depiction in a drawing does not imply that the illustrated process is exclusive of other variations and modifications thereto, does not imply that the illustrated process or any of its steps are necessary to the invention, and does not imply that the illustrated process is preferred.

[0101] Although a process may be described as including a plurality of steps, that does not indicate that all or even any of the steps are essential or required. Various other embodiments within the scope of the described invention(s) include other processes that omit some or all of the described steps. Unless otherwise specified explicitly, no step is essential or required.

[0102] Although a product may be described as including a plurality of components, aspects, qualities, characteristics and/or features, that does not indicate that all of the plurality are essential or required. Various other embodiments within the scope of the described invention(s) include other products that omit some or all of the described plurality.

[0103] An enumerated list of items (which may or may not be numbered) does not imply that any or all of the items are mutually exclusive, unless expressly specified otherwise. Likewise, an enumerated list of items (which may or may not be numbered) does not imply that any or all of the items are comprehensive of any category, unless expressly specified otherwise. For example, the enumerated list "a computer, a laptop, a PDA" does not imply that any or all of the three items of that list are mutually exclusive and does not imply that any or all of the three items of that list are comprehensive of any category.

[0104] Headings of sections provided in this patent application and the title of this patent application are for convenience only, and are not to be taken as limiting the disclosure in any way.

[0105] "Determining" something can be performed in a variety of manners and therefore the term "determining" (and like terms) includes calculating, computing, deriving, looking up (e.g., in a table, database or data structure), ascertaining and the like

[0106] The terms "including", "comprising" and variations thereof mean "including but not limited to", unless expressly specified otherwise. As used herein, “comprising” means “including,” and the singular forms “a” or “an” or “the” include plural references unless the context clearly dictates otherwise. The term “or” refers to a single element of stated alternative elements or a combination of two or more elements, unless the context clearly indicates otherwise

[0107] A description of an embodiment with several components or features does not imply that all or even any of such components and/or features are required. On the contrary, a variety of optional components are described to illustrate the wide variety of possible embodiments of the present invention(s). Unless otherwise specified explicitly, no component and/or feature is essential or required.

[0108] Further, although process steps, algorithms or the like may be described in a sequential order, such processes may be configured to work in different orders. In other words, any sequence or order of steps that may be explicitly described does not necessarily indicate a requirement that the steps be performed in that order. The steps of processes described herein may be performed in any order practical. Further, some steps may be performed simultaneously despite being described or implied as occurring non-simultaneously (e.g., because one step is described after the other step). Moreover, the illustration of a process by its depiction in a drawing does not imply that the illustrated process is exclusive of other variations and modifications thereto, does not imply that the illustrated process or any of its steps are necessary to the invention, and does not imply that the illustrated process is preferred.

[0109] While several embodiments of the present disclosure have been described and illustrated herein, those of ordinary skill in the art will readily envision a variety of other means and/or structures for performing the functions and/or obtaining the results and/or one or more of the advantages described herein, and each of such variations and/or modifications is deemed to be within the scope of the present disclosure. More generally, those skilled in the art will readily appreciate that all parameters, dimensions, materials, and configurations described herein are meant to be exemplary and that the actual parameters, dimensions, materials, and/or configurations will depend upon the specific application or applications for which the teachings of the present disclosure is/are used.

[0110] Those skilled in the art will recognize, or be able to ascertain using no more than routine experimentation, many equivalents to the specific embodiments of the disclosure described herein. It is, therefore, to be understood that the foregoing embodiments are presented by way of example only and that, within the scope of the appended claims and equivalents thereto, the disclosure may be practiced otherwise than as specifically described and claimed. The present disclosure is directed to each individual feature, system, article, material, kit, and/or method described herein. In addition, any combination of two or more such features, systems, articles, materials, kits, and/or methods, if such features, systems, articles, materials, kits, and/or methods are not mutually inconsistent, is included within the scope of the present disclosure.

[0111] All definitions, as defined and used herein, should be understood to control over dictionary definitions, definitions in documents incorporated by reference, and/or ordinary meanings of the defined terms.

[0112] The indefinite articles “a” and “an,” as used herein in the specification and in the claims, unless clearly indicated to the contrary, should be understood to mean “at least one.”

[0113] The phrase “and/or,” as used herein in the specification and in the claims, should be understood to mean “either or both” of the elements so conjoined, i.e. , elements that are conjunctively present in some cases and disjunctively present in other cases. Other elements may optionally be present other than the elements specifically identified by the “and/or” clause, whether related or unrelated to those elements specifically identified, unless clearly indicated to the contrary.

[0114] Reference throughout this specification to “one embodiment” or “an embodiment” means that a particular feature, structure, or characteristic described in connection with the embodiment is included in at least one embodiment. Thus, appearances of the phrases “in one embodiment” or “in an embodiment” in various places throughout this specification are not necessarily all referring to the same embodiment. Furthermore, the particular features, structures, or characteristics may be combined in any suitable manner in one or more embodiments.

[0115] The disclosure of numerical ranges should be understood as referring to each discrete point within the range, inclusive of endpoints, unless otherwise noted. Unless otherwise indicated, all numbers expressing quantities of components, molecular weights, percentages, temperatures, times, and so forth, as used in the specification or claims are to be understood as being modified by the term “about.” Accordingly, unless otherwise implicitly or explicitly indicated, or unless the context is properly understood by a person of ordinary skill in the art to have a more definitive construction, the numerical parameters set forth are approximations that may depend on the desired properties sought and/or limits of detection under standard test conditions/methods, as known to those of ordinary skill in the art. When directly and explicitly distinguishing embodiments from discussed prior art, the embodiment numbers are not approximates unless the word “about” is recited. Whenever “substantially,” “approximately,” “about,” or similar language is explicitly used in combination with a specific value, variations up to and including ten percent (10%) of that value are intended, unless explicitly stated otherwise.

[0116] Directions and other relative references may be used to facilitate discussion of the drawings and principles herein, but are not intended to be limiting. For example, certain terms may be used such as “inner,” “outer,”, “upper,” “lower,” “top,” “bottom,” “interior,” “exterior,” “left,” right,” “front,” “back,” “rear,” and the like. Such terms are used, where applicable, to provide some clarity of description when dealing with relative relationships, particularly with respect to the illustrated embodiments. Such terms are not, however, intended to imply absolute relationships, positions, and/or orientations. For example, with respect to an object, an “upper” part can become a “lower” part simply by turning the object over. Nevertheless, it is still the same part and the object remains the same.

[0117] The terms and expressions which have been employed herein are used as terms of description and not of limitation, and there is no intention, in the use of such terms and expressions, of excluding any equivalents of the features shown and described (or portions thereof), and it is recognized that various modifications are possible within the scope of the claims. Accordingly, the claims are intended to cover all such equivalents.

VIII. Conclusion

[0118] Any of the features illustrated or described with respect to FIGS. 1 A-5 and Clauses 1-42 can be combined with any other features illustrated or described with respect to FIGS. 1A-5 and Clauses 1-42 to provide systems, assemblies, kits, devices, methods, and embodiments not otherwise illustrated or specifically described herein. All features described herein are independent of one another and, except where structurally impossible, can be used in combination with any other feature described herein.

[0119] The present disclosure provides, to one of ordinary skill in the art, an enabling description of several embodiments and/or inventions. Some of these embodiments and/or inventions may not be claimed in the present application, but may nevertheless be claimed in one or more continuing applications that claim the benefit of priority of the present application. Applicants intend to file additional applications to pursue patents for subject matter that has been disclosed and enabled but not claimed in the present application.

[0120] It will be understood that various modifications can be made to the embodiments of the present disclosure herein without departing from the scope thereof. Therefore, the above description should not be construed as limiting the disclosure, but merely as embodiments thereof. Those skilled in the art will envision other modifications within the scope of the invention as defined by the claims appended hereto.

Claims

CLAIMS What is claimed is:

1 . A blow-fill-seal (BFS) assembly comprising: at least one BFS vial, each BFS vial comprising: a first chamber containing a fluid therein; and a neck portion in fluid communication with the first chamber, wherein the BFS vial has a first end and a second end along a longitudinal direction, the first chamber being disposed between the second end and the neck portion along the longitudinal direction, the neck portion has a first wall at the first end of the BFS vial that defines a fluid seal, the BFS vial has a parting line defined by a first plane parallel to the longitudinal direction, the first wall defining the fluid seal has, at the parting line, a first thickness along the longitudinal direction, the first chamber is defined by a second wall extending along the longitudinal direction, the second wall having a second thickness along a radial direction perpendicular to the longitudinal direction, and the first thickness is greater than the second thickness.

2. The BFS assembly of claim 1 , wherein the first thickness is equal to or greater than 1.1 times the second thickness.

3. The BFS assembly of claim 1 , wherein the second thickness is along a direction substantially perpendicular to the first plane.

4. The BFS assembly of claim 1 , further comprising: a second chamber disposed between the second end and the first chamber; or a second chamber disposed between the neck portion and the first chamber.

5. The BFS assembly of claim 4, wherein the first and second chambers are separated from each other by a constriction.

6. The BFS assembly of claim 1 , wherein the BFS assembly is formed of a plastic.

7. The BFS assembly of claim 6, wherein the plastic comprises polyethylene or polypropylene.

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8. The BFS assembly of claim 1 , wherein the fluid seal of each BFS vial is constructed for penetration by a needle of a respective administration assembly when the administration assembly is coupled to the neck portion of the BFS vial, so as to provide a fluid path from the first chamber to an exterior of the BFS vial.

9. The BFS assembly of claim 1 , wherein a volume of fluid in each first chamber is less than 1 -mL.

10. The BFS assembly of claim 1 , wherein the fluid in each first chamber comprises a medicament.

11 . The BFS assembly of claim 1 , wherein each BFS vial further comprises one or more flange portions extending radially outward from the first chamber along the first plane.

12. The BFS assembly of claim 11 , wherein the at least one BFS vial is a plurality of BFS vials arranged in an array, with facing flange portions connecting adjacent BFS vials together.

13. The BFS assembly of claim 12, wherein the array has at least five BFS vials.

14. The BFS assembly of claim 13, wherein the array has at least twenty-five BFS vials.

15. The BFS assembly of claim 12, wherein the neck portion of each BFS vial is separated from the neck portion of an adjacent BFS vial in the array by an open gap.

16. A method for fabricating a blow-fill-seal (BFS) assembly comprising at least one BFS vial, the method comprising:

(i) a first recess for forming at least part of the first chamber;

(ii) a second recess for forming the neck portion;

(iii) a pinch surface disposed at and substantially parallel to a contact plane of the respective mold half and bounding at least a portion of the second recess; (iv) a dam surface disposed on a side of the pinch surface opposite from the second recess and connected to the pinch surface via a first angled surface, the dam surface being substantially parallel to the contact plane and spaced from the contact plane by a first distance; and

(d) after (c), sealing, using a second mold of the plurality of molds in the rotary BFS machine, the first chamber of BFS vial with the fluid therein.

17. The method of claim 16, wherein, after (b): each BFS vial has a first end and a second end along a longitudinal direction, the first chamber being disposed between the second end and the neck portion along the longitudinal direction, the neck portion has a first wall at the first end of the BFS vial that defines a fluid seal, the first wall defining the fluid seal has, at the parting line, a first thickness along the longitudinal direction, the first chamber is defined by a second wall extending along the longitudinal direction, the second wall having a second thickness along a radial direction perpendicular to the longitudinal direction, and the first thickness is greater than the second thickness.

18. The method of claim 17, wherein the first thickness is equal to or greater than 1 .1 times the second thickness.

19. The method of claim 17, wherein the second thickness is along a direction substantially perpendicular to the first plane.

20. The method of claim 16, wherein the plastic comprises polyethylene or polypropylene.

21 . The method of claim 16, wherein, after (c), a volume of fluid filled in each first chamber is less than 1-mL.

22. The method of claim 16, wherein the fluid filled in (c) comprises a medicament.

23. The method of claim 16, wherein the molding of (b) is such that one or more flange portions are formed that extend radially outward from the first chamber of each BFS vial.

24. The method of claim 16, wherein the at least one BFS vial is a plurality of BFS vials arranged in an array with facing flange portions connecting adjacent BFS vials together.

25. The method of claim 24, wherein (b)-(d) are such that at least five BFS vials are simultaneously formed for the BFS assembly.

26. The method of claim 24, wherein, after (d), the neck portion of each BFS vial is separated from the neck portion of an adjacent BFS vial in the array by removable flashing.

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