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: 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is introduced through the injection member and into the sterile chamber of the device, the injection member is then withdrawn from the septum, the septum reseals itself at the resulting penetration aperture, and the chamber is maintained sterile throughout the foregoing steps.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 aseptic transfer of fluid therethrough. A first portion includes a closure and a piercing member comprising a hollow shaft for flowing fluid therethrough, and at least one port in fluid communication with the interior of the hollow shaft for passage of the fluid therethrough. 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). A second portion includes a pierceable septum. The first and second portions are engageable such that the piercing member pierces the pierceable septum. When the pierceable member has at least partially penetrated the pierceable septum, the closure and/or the shaft moves from the first position to the second position for aseptical transfer of fluid.

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: 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: 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: 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: Apparatus for filling devices that are penetrable for filling the devices with a substance, and resealable for sealing the resulting hole. A device support supports at least one such device in a substantially fixed position relative to the support during filling and/or resealing. A manifold drivingly mounted over the device support can include (1) a cartridge including a filling needle for penetrating a resealable stopper and introducing a substance therethrough into the device, a mount for mounting the cartridge on the manifold, and a removable cover releasably coupled to the mount for covering the filling needle during transportation, installation and/or removal of the cartridge from the manifold. The manifold can include a thermal source for heating a penetrated region of the stopper and, sealing the hole.

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: A sterilizing apparatus and related method are provided for sterilizing an object, such as a container. The sterilizing apparatus may include a housing, a source of fluid sterilant, a fluid sterilant station for transmitting fluid sterilant onto a surface of the object, a flow system for circulating air or gas within the housing, a system for removing fluid sterilant from the surface of the object, and a system for evacuating fluid sterilant from the housing. The container may include a body defining a storage chamber for receiving a product, and a container closure. A sealing portion may be engageable with the body to form a substantially dry hermetic seal between the container closure and body.

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: 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 is provided for receiving a substance, and includes a body defining a chamber for receiving the substance; and a dome-shaped needle penetrable and resealable portion that is penetrable by the needle for aseptically filling introducing substance into the chamber. The penetrable and resealable portion includes an injection member contacting member configured to contact and wipe the injection member during movement of the injection member therethrough, and is resealable to seal the product from ambient atmosphere within the 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: 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: An aseptic fluid connector having a male connector and a female connector engageable to aseptically transfer fluid therethrough. The male connector includes a closure and a piercing member comprising a hollow shaft for receiving fluid therein, a tip, and at least one port in fluid communication with the interior of the hollow shaft for passage of the fluid therethrough. 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). The female connector includes a pierceable septum. The male and female connector are engageable such that the piercing member pierces the pierceable septum. Only when the pierceable member has fully penetrated the pierceable septum can the closure and/or the shaft move from the first position, to the second position to aseptically transfer fluid therethrough.

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: 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: 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 storage chamber within the body for storing multiple doses of the substance therein, a sterile filter configured to sterilize air or other gas flowing into the storage chamber through the filter, 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 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.