Abstract: A multiple dose syringe has a first valve defining a first valve opening pressure and a second valve defining a second valve opening pressure. A storage chamber in fluid communication with the second valve stores multiple doses of a substance therein and includes an outlet for dispensing multiple doses of the stored substance therethrough. A compression surface is movable between first and second positions and defines a compression chamber between the compression surface and the first valve. Movement of the compression surface in a direction from the first position toward the second position dispenses substance in the compression chamber through the first valve and out of the syringe. Movement of the compression surface in a direction from the second position toward the first position causes substance to flow from the storage chamber through the second valve and into the compression chamber.

Abstract: A needle has a hollow shaft, a tip formed at one end of the shaft, one or more ports in fluid communication with the interior of the hollow shaft, and a closure. The closure and/or the shaft is movable between (i) a first position wherein the closure closes the port(s), and (ii) a second position opening the port(s).

Abstract: Device for preventing needle reuse and injury has a needle cap or enclosure, a body, and a needle. The needle cap and/or body is movable relative to the other from (i) a first position wherein the needle is received within and enclosed by the needle cap to prevent needle injury; (ii) to a second position wherein the needle is passed through the needle cap to penetrate tissue; and (iii) to a third position wherein the needle is within and enclosed by the needle cap, and the needle cap and body are locked to prevent needle reuse and injury. The needle cap conceals the needle from view before, during and after the patient injection. An intra-needle one-way valve allows liquid flow therethrough in a direction from an inlet toward an outlet of the needle, and prevents liquid flow in an opposite direction to prevent cross-contamination between the needle and a syringe.

Abstract: An injection member penetrates an elastic septum of a device defining a sealed, empty, sterile chamber in fluid communication with the septum. During penetrating, an annular interface is formed between the septum and the injection member extending axially between a penetration point on an interior surface of the septum in fluid communication with the sterile chamber, and an exterior surface of the septum engaging the injection member. The injection member is de-contaminated by (i) friction between the septum and injection member at the annular interface, and (ii) elongation of the septum at the annular interface. A substance is introduced through the injection member and into the sterile chamber of the device, the injection member is then withdrawn from the septum, the septum reseals itself at the resulting penetration aperture, and the chamber is maintained sterile throughout the foregoing steps.

Abstract: An apparatus for filling a device having a penetrable septum and a sealed chamber. The apparatus includes a filling member engageable with the penetrable septum to penetrate the septum, port(s), and a closure. The closure and filling member are movable between (i) a first position wherein the closure closes the port(s), and (ii) a second position opening the port(s). The filling member and/or septum is movable relative to the other between (i) a first position wherein the filling member is spaced from the septum, and (ii) a second position wherein the filling member is penetrated through the septum and in communication with the sealed chamber. A locking device is movable between (i) a locked position locking the closure and/or filling member in the first position, and (ii) an unlocked position allowing movement of the closure and/or filling member relative to the other and into the second position.

Abstract: An apparatus and method for electronically tracing primary devices and process devices, and closed transfer formulation and/or filling the traced primary devices. Each of the primary devices and process devices includes an electronic identifier, such as an RFID tag or barcode. Scanners read the electronic identifiers, and transmit the read identification information to a controller. The controller compares the read identification information to required identification information for a respective product specification, and transmits a signal to further proceed with a formulation or filling process, or not, based on the comparison.

Abstract: A septum is penetrable by a needle for decontamination by physical interaction. The septum can include a peripheral portion, an exterior surface, and an interior surface. A penetration portion extends between the exterior and interior surfaces, is spaced inwardly of the peripheral portion, and is penetrable by the needle or other penetrating element. A flex portion is located between the penetration portion and the peripheral portion. A thicker portion extends between the flex portion and the penetration portion, and defines an increased thickness between the exterior and interior surfaces relative to the flex portion. The flex portion is flexible inwardly relative to the peripheral portion during penetration of the penetration portion by a needle or other penetrating element. The penetration portion physically interacts with and decontaminates the needle when it penetrates the septum. The septum may also reduce or prevent retrograde contamination when the needle is withdrawn.

Abstract: Apparatuses and methods for controlling transfer of substances to a formulation container to provide a predetermined formulation. A controller may utilize one or more of a flow time, flow rate or a volume of transfer of substance. Barcoded and RFID-containing components may be used to determine what connection or disconnection has been made, and/or time thereof. Process compliance may compare measured or determined flow or connection time, flow rate and/or the transfer volume to a predetermined time, flow rate and/or volume, and adjust one or more of the time, flow rate and/or the volume of the transfer. An optional holder or cradle is configured to receive therein a fluid transfer connector formed by the connection of first and second connector portions, each in fluid communication with a flow conduit or channel that delivers substance to or receives substance from its respective connector portion, only if the connector portions are properly connected together.

Abstract: A device comprises a first portion including a first polymer, and a second portion that is relatively flexible in comparison to the first portion and includes a second polymer that is substantially not bondable to the first polymer. A chamber of the device is hermetically sealable with respect to ambient atmosphere and is defined by (i) an interior of the second portion, and/or (ii) a space formed between the first and second portions. A third portion of the device includes a third polymer that is bondable to the first and second polymers and fixedly secures the first and second portions to each other.

Abstract: A pouch comprises a film including (i) a fold defining a fold plane and a first marginal edge portion of the pouch, (ii) a first side transverse to the fold plane, and (iii) a second side opposite the first side and transverse to the fold plane. A fitment of the pouch includes a port and a base. The base defines a mid-portion engaging the fold at the fold plane, a first side located on one side of the mid-portion, and a second side located on an opposite side of the mid-portion relative to the first side. The first and second sides of the base are transverse to the fold plane, and are engaged with the first or second sides of the film, respectively. The base or film overlaps the other and defines an overlapping region. The base and film are sealed to each other within the overlapping region and form a fluid-tight seal that extends about the port.

Abstract: A flexible pouch and valve assembly is provided for aseptically storing a substance, dispensing multiple portions of the stored substance therefrom, and maintaining substance remaining in the pouch in an aseptic condition sealed with respect to ambient atmosphere. The flexible pouch and valve assembly are receivable within a relatively rigid housing, and are adapted to cooperate with a pump for pumping discrete portions of substance from the pouch and through the one-way valve to dispense the substance therefrom. The assembly comprises a flexible pouch defining therein a variable-volume storage chamber sealed with respect to the ambient atmosphere for aseptically storing therein multiple portions of the substance. A one-way valve of the assembly includes a valve body defining an axially-extending valve seat and at least one flow aperture extending through the valve body and/or the valve seat.

Abstract: Connector assembly including a piercing member having a flow port therein attached to a first piece, with the piercing member slidingly receivable within a second piece, wherein the piercing member and the second pierce are movable relative to each other between a first position where the second pieces closes the flow port and a second position where the flow port is open. The first piece contains a locking mechanism that lockingly engages with a device when connected thereto, preventing subsequent disconnection of first piece and the device. Upon initial connection of the first piece to the device, the second piece is moved from the first position to the second position.

Abstract: A dispenser has a body with a variable-volume storage chamber for storing substance, and a dispensing portion defining a dosage chamber in fluid communication with the storage chamber. A first valve includes a valve seat and a flexible valve cover seated thereon defining a normally-closed fluid-tight seam therebetween. The valve cover relative to moves from the valve seat to allow substance through the seam and out of the dispenser. A second valve allows substance from the storage chamber into the dosage chamber and substantially prevents flow from the dosage chamber into the storage chamber. An actuator is manually movable between (i) a first non-actuated position, and (ii) a second actuated position extending into the dosage chamber for compressing a dose of substance therein, dispensing substance through the first valve. The elasticity of the actuator causes it to return to the first non-actuated position upon manually releasing the actuator.

Abstract: A device comprises a first portion including a first polymer, and a second portion that is relatively flexible in comparison to the first portion and includes a second polymer that is substantially not bondable to the first polymer. A chamber of the device is hermetically sealable with respect to ambient atmosphere and is defined by (i) an interior of the second portion, and/or (ii) a space formed between the first and second portions. A third portion of the device includes a third polymer that is bondable to the first and second polymers and fixedly secures the first and second portions to each other.

Abstract: Apparatuses and methods for controlling transfer of substances to a formulation container to provide a predetermined formulation. A controller may utilize one or more of a flow time, flow rate or a volume of transfer of substance. Barcoded and RFID-containing components may be used to determine what connection or disconnection has been made, and/or time thereof. Process compliance may compare measured or determined flow or connection time, flow rate and/or the transfer volume to a predetermined time, flow rate and/or volume, and adjust one or more of the time, flow rate and/or the volume of the transfer. An optional holder or cradle is configured to receive therein a fluid transfer connector formed by the connection of first and second connector portions, each in fluid communication with a flow conduit or channel that delivers substance to or receives substance from its respective connector portion, only if the connector portions are properly connected together.

Abstract: A multiple dose syringe has a first valve defining a first valve opening pressure and a second valve defining a second valve opening pressure. A storage chamber in fluid communication with the second valve stores multiple doses of a substance therein and includes an outlet for dispensing multiple doses of the stored substance therethrough. A compression surface is movable between first and second positions and defines a compression chamber between the compression surface and the first valve. Movement of the compression surface in a direction from the first position toward the second position dispenses substance in the compression chamber through the first valve and out of the syringe. Movement of the compression surface in a direction from the second position toward the first position causes substance to flow from the storage chamber through the second valve and into the compression chamber.

Abstract: A valve comprises a shell, a flexible valve member sealingly mounted within the shell, and a valve body mounted atop the flexible valve member within the shell. The flexible member is moveable between closed and open positions to allow the flow of fluid therethrough. The valve is engageable with a filling device having flow ports and a surrounding closure. The closure and/or the shaft is movable between (i) a first position wherein the closure closes the port(s), and (ii) a second position opening the port(s). Alternatively, the valve may comprise a portion of a female connector and the filling device may comprise a portion of a male connector to form an aseptic fluid connector for the aseptic transfer of fluid therethrough.

Abstract: An injection member penetrates an elastic septum of a device defining a sealed, empty, sterile chamber in fluid communication with the septum. During penetrating, an annular interface is formed between the septum and the injection member extending axially between a penetration point on an interior surface of the septum in fluid communication with the sterile chamber, and an exterior surface of the septum engaging the injection member. The injection member is de-contaminated by (i) friction between the septum and injection member at the annular interface, and (ii) elongation of the septum at the annular interface. A substance is introduced through the injection member and into the sterile chamber of the device, the injection member is then withdrawn from the septum, the septum reseals itself at the resulting penetration aperture, and the chamber is maintained sterile throughout the foregoing steps.

Abstract: A device includes a first part having a co-molded first support, valve cover and elastic actuator, and a second part having an injection molded second support, valve seat, and variable-volume storage chamber pre-form. The pre-form is blow molded into a flexible pouch defining the variable-volume storage chamber. The one-way valve includes a semi-annular, curvilinear, relatively rigid valve seat defining axially-extending, opposing first marginal portions, and an axially-extending first mid-portion angularly extending between the opposing first marginal portions. A flexible valve member is superimposed on the valve seat and defines axially-extending, opposing second marginal portions fixedly secured on or adjacent to respective first marginal portions of the valve seat, and an axially-extending second mid-portion angularly extending between the opposing first marginal portions and superimposed onto the first mid-portion of the valve seat.

Abstract: An apparatus and method for sterile filling comprises de-contaminating a needle penetrable surface of a device including a needle penetrable septum and a sealed chamber in fluid communication with the needle penetrable septum. A filling needle penetrates the needle penetrable septum, introduces substance through the filling needle and into the chamber and is, in turn, withdrawn from the septum. A liquid sealant is applied to the penetrated region of the septum. Radiation or energy is applied to the liquid sealant to cure the liquid sealant from a liquid phase to a solid phase.