Abstract: A syringe includes a plunger having multiple sections of differing diameters or materials, and a barrel with a cavity into which the plunger is inserted. The barrel includes a first probe and a second probe opposite to one another such that an interior volume of the barrel is radially between the first and second probes. A microcontroller is configured to measure a capacitance between the first and second probes, with the measured capacitance having a first capacitance value when the first section of the plunger shaft is between the first and second probes and a second capacitance value different from the first capacitance value when a second section of the plunger shaft is between the first and second probes. The microcontroller is configured to determine that an injection has been completed when the second capacitance value is measured.

Abstract: A syringe nest is provided that includes a planar base and a plurality of nesting units extending from and interconnected by the base. Each nesting unit includes a hollow hexagonal body having a first open end and an opposing second open end.

Abstract: Various systems for the containment or delivery of a product are provided. The systems allow for the storage of products at low temperatures and include a container closure inserted into a container (10). The container closure may have an elastomeric body (12) and include a material (14) having a negative coefficient of thermal expansion. In other systems, the material having a negative coefficient of thermal expansion may be inserted between the elastomeric container closure and a seal. Other systems may include an insert at least partially embedded within the elastomeric body of a container closure, an actuator having a distal end movably attached to the insert, and a resilient element between the distal end of the actuator and the insert, wherein the resilient material expands radially upon displacing the distal end of the actuator toward the insert.

Abstract: A fluid-dispensing syringe includes a barrel and a plunger assembly disposed within the barrel. The assembly includes a piston with an outer piston surface, an inner piston cavity with an inner piston surface and at least one female thread, and proximal and distal piston ends. The plunger rod includes a rod body having proximal and distal rod ends, with a threaded extension extending distally from the distal rod end. The threaded extension extends distally along a distal length and threadedly engages the at least one female thread along a portion of the distal length. The threaded extension has a ventilation feature configured to create a ventilation space between the threaded extension and the inner piston surface. The proximal piston end and the distal rod end are in spaced relation to form a primary fluid passageway portion from outside of the plunger assembly into the piston cavity.

Abstract: A vial closure assembly for sealing a container includes a ring, a cap, a shell, and an optional cover. The ring has a first top wall defining a first through-opening and a skirt extending downwardly from the first top wall that includes a plurality of locking tabs. The cover includes a second top wall defining a second through-opening, a sidewall extending downwardly from the second top wall, and an interior cavity defined by the second top wall and the sidewall. The cap includes a plurality of tabs configured to engage the first or second top wall. The shell includes a body having an inwardly radially extending upper and lower lip. The upper lip includes at least one rail for sliding contact with a top surface of either the first or second top wall.

Abstract: An injection device includes a lower housing, a needle guard and an upper housing. With the upper housing in a pre-use position and the needle guard in a first position, an abutment body of an arm of the upper housing abuts a catch of the lower housing, preventing the upper housing from moving distally relative to the lower housing toward a dispensed position. Proximal movement of the needle guard from the first position to a second position thereof causes proximal movement of a camming ramp of a leg of the needle guard with respect to the catch and the abutment body such that the camming ramp engages the arm, thereby deflecting the abutment body radially outwardly by a distance sufficient to allow the abutment body to pass radially outside of the catch, and, in turn, permits the distal movement of the upper housing into the dispensed position of the upper housing.

Abstract: A device and method for measuring a volume of liquid expelled from a syringe is provided. The device generally includes a syringe barrel, a plunger actuated with a plunger rod, and a sensor. The sensor may include two ports with one port being in fluid communication with a source of fluid external to the syringe barrel, while the second port is in fluid communication either with a proximal end portion of the syringe barrel or a hollow plunger rod having a first end closed by the plunger. The method may include expelling liquid from the syringe; detecting and recording differential pressure with the sensor over time; and calculating the volume of liquid expelled from the syringe from the recorded differential pressure over time.

Abstract: Systems and methods for determining Container Closure Integrity (CCI) in a container system comprising a container, an elastomeric stopper, and a retainer for retaining the stopper in place are disclosed. The systems and methods involve disposing, within a seal assembly, a component configured to sense a degree of compression of the elastomeric stopper. In a first implementation, the elastomeric stopper comprises an embedded positioning component embedded within the elastomeric material. The position of the positioning component is sensed using a detection system and the integrity of the closure is determined based on the position of the embedded component. In a second implementation, a force sensitive resistor is disposed within the seal stack to measure the compression of the elastomeric stopper. The compression of the elastomeric stopper is correlated to the integrity of the seal.

Abstract: A piston having a longitudinal axis and opposing proximal and distal axial ends is manufactured by a method including molding a partially formed piston body and then molding the piston. The partially formed piston body is molded by placing a first rubber sheet and an inert film between die plates of a first forming tool, vulcanizing the first rubber sheet and the inert film between the die plates of the first forming tool, and blanking out the partially formed piston body from the first rubber sheet and the inert film. The piston is then molded by placing the partially formed piston body into a second forming tool, placing a second rubber sheet into the second forming tool, vulcanizing the second rubber sheet and the partially formed piston body together, and blanking out the piston from the second rubber sheet at a trim edge spaced apart from the inert film.

Abstract: An elastomeric article for sealing a container includes an elastomeric body having an external sidewall surface and an external crown surface and a first fluoropolymer film layer having an internal surface and an external surface. The internal surface of the first fluoropolymer film layer is laminated to an entirety of the external sidewall and crown surfaces of the elastomeric body. The external crown surface of the first fluoropolymer film layer includes a drug contact surface configured to contact a drug contained in the container and the external sidewall surface including a sealing surface for contacting an interior surface of the container. The external surface of the first fluoropolymer film layer is substantially free of striations.

Abstract: A method of manufacturing a medical component includes molding a first member of the medical component from an elastomeric material. The first member includes a first end defined by a closed base wall, an opposing second end which is an open end, a sidewall extending between the first and second ends, and an internal recess to receive at least one electronic device. The method further includes positioning the electronic device within the recess of the first member to form an assembly, such that the electronic device is received in an inverted open cavity defined by the sidewall. The method further includes applying a protective film on the second end of the first member, such that the protective film covers an exposed surface of the electronic device. In addition, the method includes overmolding the assembly with the elastomeric material to form the medical component having the electronic device embedded therein.

Abstract: A container for storing a pharmaceutical composition includes a body portion having an elastomeric material, and an inner lining having a thermoplastic material covering at least a portion of an inner surface of the body portion. The container forms an internal chamber for storing the pharmaceutical composition, where the internal chamber is bounded by the inner surface of the body portion. The inner lining provides a barrier between the elastomeric material and the pharmaceutical composition, thus protecting the pharmaceutical composition. Associated methods of storing the pharmaceutical composition within the container, as well as manufacturing the container, are also described.

Abstract: An assembly for a container to be filled with a pharmaceutical drug is provided. The assembly includes a first component and a second component. The first component has at least one electronic device fully embedded therein, a first end provided with a first engagement feature and an opposing second end. The second component has a second engagement feature configured to engage the first engagement feature of the first component.

Abstract: An injection system includes a handle assembly with a handle body having an outer surface surrounding a handle body interior and a plunger extending therethrough. A tubular handle collar is telescopically received in the handle body exterior and is axially movable with respect to the handle body. A syringe housing assembly is selectively connectable to the handle assembly and includes a syringe housing and a tubular syringe sleeve telescopically received through a distal end of the syringe housing and axially movable with respect thereto. The syringe housing has an exterior side surface surrounding a syringe housing interior configured to receive at least a portion of a syringe. The syringe sleeve has a proximal end, a distal end with a skin contact surface, and a generally cylindrically-shaped outer surface.

Abstract: A packaging system for sealing a medicine container having a filling opening with a stopper includes a container tray having a container cell for receiving and stabilizing the medicine container. A shuttle has an exterior surface and an interior surface. The interior surface is configured for releasably securing the stopper. The shuttle is configured to release the stopper into the fill opening upon application of a releasing force to the exterior surface of the shuttle. A shuttle tray has a shuttle cell. The shuttle cell forms a body with a proximal opening, an interior space, a bottom inner surface opposite the proximal opening, and a side inner surface. The shuttle cell releasably secures the shuttle.

Abstract: A flexible collar including a rigid body having a cylindrical outer surface and a cylindrical inner surface concentrically aligned with respect to a common longitudinal axis, a top surface, and a bottom surface, the inner surface defining a bore from the top surface to the bottom surface, and each of the top and bottom surfaces having an endless pathway confined to a respective plane and circumscribing a respective edge of the inner surface. The flexible collar further includes at least one accordion region having a plurality of pivots, at least two of the pivots being radially spaced apart from the longitudinal axis at different distances, and the accordion region being configured to radially deform.

Abstract: An injection system, including an injector having a dispensing mechanism configured to dispense a medicament, and a ready-to-use indicator. The ready-to-use indicator includes a controller configured to interact with the ready-to-use indicator and an audio and/or visual indicator, a temperature sensor, and a temperature analog having similar thermodynamic properties of the medicament. The temperature sensor is configured to detect a temperature of the temperature analog which represents the dynamic temperature of medicament as the medicament is heated or cooled. The temperature sensor is configured to communicate the detected temperature to the controller and to alert the controller when a preset temperature is reached. The ready-to-use indicator is configured to alert a user when the preset temperature is reached, signifying the medicament is thermally ready to be delivered by the dispensing mechanism. The audio and/or visual indicator is configured to display indicate one or more notifications to the user.

Abstract: A securing device for an injection device which receives a syringe with a proximal end portion having a radially outwardly projecting flange, has a body with proximal and distal end portions, an opening for accepting the syringe, an outer surface, and a proximal end surface for contacting a distally-facing surface of the flange when the syringe is advanced distally, preventing further advancement. A securing arm includes a free end; a base end fixed to the outer surface; a first portion extending radially outwardly from the base end to permit the flange to pass; and a second portion extending radially inwardly in a rest position, contacting the flange as the syringe is advanced. The securing arm is elastically flexible to allow the free end to move radially outwardly, allowing the advancing flange to pass, and is biased to the rest position to secure the flange and the syringe against proximal movement.

Abstract: A syringe system, including a plunger, a microcontroller, a battery, and a coil. The syringe barrel having a proximal end, a distal end, and a cylindrical sidewall defining a longitudinal axis, the cylindrical sidewall extending longitudinally between the proximal and distal ends, the sidewall having an exterior surface and defining an internal volume, the plunger being positioned between the proximal and distal ends of the syringe barrel and being movable within the internal volume with respect to the syringe barrel in the longitudinal direction. The syringe barrel further includes a label disposed on the sidewall and having at least two conductive strips extending in a non-parallel direction with respect to the longitudinal axis and having unique lengths. The microcontroller is configured to determine a position of the plunger with respect to the syringe barrel by measuring a current induced in the coil by the at least two conductive strips.