Abstract: A device and method are provided for storing substances separately, and for mixing the substances prior to use. The device defines at least one first chamber for receiving a first substance, and at least one second chamber for receiving a second substance. A first sealing portion is located between the first and second chambers and is movable between a closed position preventing fluid communication between the chambers, and an open position permitting fluid communication between the first and second chambers for mixing the substances. First and second penetrable and resealable portions in fluid communication with the first and second chamber(s), respectively, may be used for filling by penetrating them with an injection member and introduce the substances therethrough and into the respective chamber, and resealing the injection apertures and the substances within the respective chamber.

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 dispenser for holding multiple doses of fluids or other substances, and for dispensing the substances, has a vial, a flexible bladder received within the vial, and a variable volume storage chamber formed between the bladder and vial. A filling valve is coupled in fluid communication with the storage chamber and defines (1) a normally closed, fluid-tight position hermetically sealing the storage chamber from the ambient atmosphere, and (2) an open position allowing the passage of fluid through the valve both to evacuate the storage chamber and to introduce fluid through the valve to fill the storage chamber. A pump is coupled in fluid communication with the storage chamber for pumping fluids out of the storage chamber. A dispensing valve is coupled in fluid communication with the pump and defines (1) a normally closed, fluid-tight position preventing the passage of fluid out of the dispenser, and (2) an open position for dispensing pumped fluid therethrough.

Abstract: A dispenser has a body with a storage chamber for storing product. A one-way valve of the dispenser includes a valve seat and flexible valve cover seated on the valve seat and defining a normally-closed seam therebetween forming a fluid-tight seal between the valve cover and valve seat. The flexible valve cover is movable relative to the valve seat to allow the passage of substance through the seam and out of the dispenser.

Abstract: A container and method for filling same. The container includes a penetrable and resealable portion that is resealable, and a container body having a sealed empty chamber in fluid communication with the penetrable and resealable portion for receiving therein a substance. The resealable member may be dome-shaped or have a convex outer surface. A method of filling the container includes penetrating the penetrable and resealable portion with an injection member and introducing a substance into the chamber, withdrawing the injection member, and resealing the penetration hole in the resealable member made by the injection member during penetration.

Abstract: A vial for storing multiple doses of a substance to be dispensed into one or more syringes or other delivery devices. The vial has a body, a variable-volume storage chamber within the body for storing multiple doses of the substance therein, and a one-way valve connectable in fluid communication with a syringe or other delivery device. The one-way valve is moveable relative to the body between first and second positions (i) one of which permits the valve to open so that substance from the variable-volume storage chamber can flow therethrough and into the syringe or other delivery device connected in fluid communication therewith, and (ii) one of which prevents the valve from opening.

Abstract: An assembly includes a support and drive assembly, a first structure and a second structure. The first structure is in operable communication with and supported by the support and drive assembly. The first structure includes at least one filling or needle assembly and is adjustable to receive a plurality of filling or needle assemblies. The second structure is supported by the support and drive assembly. The second structure includes at least one seal assembly and is adjustable to receive a plurality of seal assemblies. A method includes determining a number of containers or vials that are to be filled concurrently and adjusting an assembly to include at least one filling or needle assembly and at least one seal assembly. A number of the filling or needle assemblies and the seal assemblies equals the number of containers or vials.

Abstract: A device has a first part with a valve seat and storage chamber, and a second part with a flexible valve cover and actuator. The storage chamber may be formed from a pre-form blow-molded into a flexible pouch defining a variable-volume storage chamber. The flexible valve cover and valve seat form a normally closed valve seam therebetween. The valve cover is movable in response to fluid at an inlet to the seam exceeding a valve opening pressure of the one-way valve between (i) a normally closed position with valve cover and valve seat in contact with each other and defining the normally closed seam, and (ii) a second position with at least a portion of the valve cover spaced away from the valve seat to allow the fluid to pass through the seam. The one-way valve may have anti-spritz features for using the device to dispense a substance, such as to the eye.

Abstract: A pouch connector includes a safety cap having a cap base portion and a main connector disposed opposite the safety cap. The main connector and safety cap are configured to receive a portion of a pouch therebetween. The main connector includes a piercing member for piercing the pouch, an actuating portion for actuating the piercing member and a main connector base portion. The piercing member is configured to pierce through a portion of the pouch so as to provide fluid communication between a substance inside the pouch and the interior of the main connector. A polymeric membrane is coupled to at least one of the cap base portion and the main connector base portion.

Abstract: An aseptic fluid connector having a first connector including a first fluid passageway for receiving a fluid therein; a first port in fluid communication with the first fluid passageway for passage of the fluid therethrough; and a first deflecting member. The first deflecting member includes a first engaging portion radially spaced relative to the first port, and a first valve movable between a closed position and an open position with movement of the first engaging portion between a non-deflected position and a deflected position, respectively. In the non-deflected position, the first valve is located in the closed position forming a fluid-tight seal between the first valve and first port and preventing the passage of fluid therethrough, and in the deflected position, the first valve is located in the open position allowing the aseptic passage of fluid through the first port.

Abstract: A dispenser for dispensing a fluid includes a rigid vial that has a main fluid chamber containing a fluid, and a pump assembly that is in fluid communication with the main fluid chamber and is configured to dispense a predetermined quantity of fluid from the main fluid chamber. A flexible bladder is provided which is located within the main fluid chamber and is configured to expand to fill the ullage created within the main fluid chamber during dispensing of fluid by the pump assembly. The resilient bladder tends to force itself outwardly toward the rigid vial and, in turn, increases the pressure within the main fluid chamber in comparison to the interior of the bladder to thereby prevent the ingress of air or vapors through the bladder or otherwise into the main fluid chamber.

Abstract: An outer shell and nozzle portion define therebetween a swirl chamber having a plurality of inlet flow paths and an outlet flow path. The swirl chamber may receive a plurality of substances or components from separate sources, to mix the plurality of substances in the swirl chamber, and to deliver the mixed substances or formulation through an outlet, e.g., to a connector. The substances may be sterile, and the entire flow path from the substance sources to the container may be sterile and aseptically sealed from ambient atmosphere. The outer shell and nozzle portion may be constructed of plastic or other disposable materials. The swirl chamber may be constructed to optimize the mixing of the substances through control of the velocity by which each substance enters the swirl chamber.

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 sealed, empty pouch, wherein the interior of the pouch is particle and pyrogen free, is made by (i) molding a tubular film including an inner surface and an outer surface, and blowing or otherwise directing micro-filtered air and/or other gas through the tubular film during molding; (ii) flattening the molded tubular film; (iii) sealing the flattened tubular film at spaced locations, cutting the sealed film at the spaced locations, and forming a plurality of empty pouches; (iv) over-molding a fitment to the outer surface of each of a plurality of empty pouches and forming a fluid-tight seal between the fitment and the interior of the pouch; and (v) preventing the collection of particles on the inner surface of each pouch, and the exposure of each such inner surface to an ambient atmosphere throughout steps (i) through (iv).

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 device that includes a first portion including a first polymer, a second portion including a second polymer, and a third portion defining a third polymer. The second polymer is substantially not bondable to the first polymer, and the third polymer is bondable to the first polymer and fixedly secures the first portion to the second portion. A device that includes a body and a closure and including and a first polymer, a second polymer and a third polymer, wherein the first polymer is bondable with the second polymer, and the third polymer is substantially not bondable to the first polymer.

Abstract: A dispenser has a body with a variable-volume storage chamber for storing product. A compression chamber is in fluid communication with the storage chamber for receiving substance therefrom. A one-way valve of the dispenser includes valve seat and flexible valve cover seated on the valve seat and defining a normally-closed seam therebetween forming a fluid-tight seal between the valve cover and valve seat. The flexible valve cover is movable relative to the valve seat to allow the passage of substance through the seam and out of the dispenser. A manually-engageable actuator connected to the dispensing portion is movable between first and second positions to dispense substance within the compression chamber out of the dispenser.

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 ophthalmic dispenser and method of filling and dispensing fluid stored therein. The dispenser includes a rigid housing defining a fluid-receiving chamber, a flexible bladder receivable within the fluid-receiving chamber, a pump coupled in fluid communication with the fluid-receiving chamber, and a nozzle having a valve defining an annular, axially-extending valve seat, an outlet aperture coupled in fluid communication between the valve seat and the pump, and a flexible valve cover extending about the valve seat and forming an annular, axially-extending interface therebetween.

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.