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: 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: 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 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.

Abstract: Methods and systems for measuring a component of a drug delivery or storage device are described. The method comprises providing a light source in an opposing relationship with an optical imaging sensor; positioning a sample component on a positioning stage located between the at least one light source and at least one opposing optical imaging sensor; and illuminating, with the at least one light source, the sample component. The controller is operable to capture an image of the component, determine the location of a first outer edge point PI of the captured image; rotate the sample component relative to the optical image sensor, and collect n images separated from each other by x degrees of rotation, wherein n*x is ?360 degrees. The controller may compare a measured position of the at least one outer edge point PI between the captured images to determine a degree or circular runout.

Abstract: A piston to be provided within an inner wall of a barrel of a pharmaceutical syringe for dispensing medicament retained in the barrel is described. The piston includes a body defining a central face, a cylindrical portion, and an annular curved portion between the cylindrical portion and the central face portion. The piston also includes an inert film enclosing the central face portion and at least a part of the annular curved portion. The cylindrical portion and the part of the annular curved portion are together configured to maintain a fluid-tight seal with the inner wall of the barrel. A pharmaceutical syringe is described for dispensing a medicament includes a barrel configured to retain the medicament and the piston.

Abstract: A syringe nest assembly includes a base having a first surface and an opposing second surface and a first plate movably coupled to the base. The base includes a plurality of nesting units extending upwardly away from the first surface of the base. Each nesting unit includes a hollow body having a first open end distal from the first surface of the base and an opposing second open end. The first plate has a first surface and an opposing second surface. The first plate includes a plurality of apertures extending from the first surface to the second surface of the first plate. Each aperture of the first plate is generally aligned with a respective nesting unit of the base.

Abstract: A method of manufacturing a medical component includes preparing a first sheet of an elastomeric material, arranging at least one electronic device in the first sheet of elastomeric material to obtain an elastomeric preform, and arranging the elastomeric preform in a mold and molding the elastomeric preform therein to cure the elastomeric material and form the medical component having the at least one electronic device embedded therein.

Abstract: A syringe safety system may include a sleeve. The sleeve may include a guide track formed in the sleeve. The guide track may have a guide pin retention portion, a travel portion, and a lockout portion. The syringe safety system may include a collar having a guide pin extending radially from an exterior surface of the collar. A spring may extend between and be coupled to the collar and the sleeve. A cap may engage the sleeve. The cap may be configured to retain the guide pin in the guide pin retention portion of the guide tack. When the cap is removed, the spring advances the guide pin into the travel portion of the guide track.

Abstract: A pharmaceutical syringe piston having a longitudinal axis includes a body having a central face portion with a first outer circumference and maximum first diameter. A cylindrical sealing portion proximate the central face portion has first and second axial ends and a wall extending therebetween. The wall has a second outer circumference and a second diameter essentially constant along the longitudinal axis between the first and second axial ends of the cylindrical sealing portion and is larger than the maximum first diameter. An annular curved portion has a maximum outer diameter less than the second diameter and connects the first axial end of the cylindrical sealing portion to the first outer circumference. An inert film encloses the central face portion and at least part of the annular curved portion and has an outer boundary between the first axial end of the cylindrical sealing portion and the first outer circumference.

Abstract: A plunger assembly is configured for slidable advancement through a reservoir of a vessel containing a material to be administered. The plunger assembly includes a plunger rod having a distal end configured to be inserted into the reservoir. An elastomeric plunger extending from the distal end of the plunger rod is configured to sealingly engage a sidewall of the reservoir. At least one printed circuit board is embedded within the plunger, and at least one electronic component is electrically connected with the at least one printed circuit board.