Abstract: A container is provided for storing a product, such as a fat containing liquid product, and includes a body defining a chamber for receiving the product; and a container closure including a sealing portion for sealing the product within the chamber. The container closure includes a member forming a substantially fluid-tight seal between the container closure and the body; a nipple in fluid communication with the chamber that seals the chamber with respect to the ambient atmosphere during storage of the product in the chamber and that can be opened to dispense product from the chamber therethrough; and a needle penetrable and laser resealable portion that is penetrable by the needle for aseptically filling the chamber with the product, and that is thermally resealable by the application of laser radiation thereto to seal the product within the chamber.

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 stopper and container body are molded in the same molding machine. An assembly device, such as a pick and place robot, transfers the stopper from one mold cavity into the opening in the container body located within another mold cavity, or vice versa, to assemble the stopper and container body. Then, the assembled container body and stopper are removed from the molding machine and transported to a needle filling and laser resealing station for filling and laser resealing. A laminar flow source directs a substantially laminar flow of air or sterile gas over the mold surfaces, stoppers and container bodies, and assembly device, to prevent contamination during assembly.

Abstract: A method for storing fluid and dispensing multiple portions of the stored fluid uses a container defining a variable-volume storage chamber; a dispensing valve including a valve inlet coupled in fluid communication with the variable-volume storage chamber, and an elastic valve member in fluid communication with the valve inlet and defining a normally-closed valve opening; a manually engageable actuator; and a pump including a compressible member defining a compression chamber coupled in fluid communication with the variable-volume storage chamber. Multiple portions of the stored fluid are hermetically sealed in the variable-volume storage chamber. The actuator is manually engageable and movable between (i) a first position wherein the compression chamber defines a first volume, and (ii) a second position wherein the compression chamber defines a second volume less than the first volume.

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 method for sterilizing a container is provided where a penetrable septum of a sealed empty device is penetrated with an injection member. A fluid sterilant is then injected through the injection member and into an interior chamber of the device. The fluid sterilant is allowed to reside within the chamber a sufficient amount of time to render the chamber either sterile or bactericidal. Product can then be introduced through the septum into the sterile or bactericidal chamber. The resulting penetration aperture is then resealed to hermetically seal the product within the chamber.

Abstract: An apparatus for storing fluid and dispensing multiple portions of the stored fluid has a container defining a variable-volume storage chamber; a dispensing valve including a valve inlet coupled in fluid communication with the variable-volume storage chamber, and an elastic valve member in fluid communication with the valve inlet and defining a normally-closed valve opening; a manually engageable actuator; and a pump including a compressible member defining a compression chamber coupled in fluid communication with the variable-volume storage chamber. Multiple portions of the stored fluid are hermetically sealed in the variable-volume storage chamber. The actuator is manually engageable and movable between (i) a first position wherein the compression chamber defines a first volume, and (ii) a second position wherein the compression chamber defines a second volume less than the first volume.

Abstract: Device and method for needle penetrating and filling a chamber with a predetermined substance, and hermetically resealing a resulting needle hole in the device by applying radiation thereto. The needle penetrable and resealable portion defines a predetermined wall thickness in an axial direction thereof, and may include a thermoplastic that substantially prevents the formation of particles released into the chamber from the needle penetrable and resealable portion during penetration by and withdrawal of the needle. Such thermoplastic may include a predetermined amount of pigment that allows the thermoplastic to substantially absorb laser radiation at a predetermined wavelength, substantially prevent the passage of radiation through the predetermined wall thickness thereof, and hermetically seal a needle aperture formed in the needle penetration region thereof in a predetermined time period.

Abstract: A sterile enclosure contains a transfer module defining a window. A port covers the window to maintain the inside of the enclosure as a sealed and sterile environment. A sliding, heated cutting element mounted on the port serves to sterilize and sever a portion of a sterile transfer bag assembly attached to the port. Preferably, the excised portion of the sterile transfer bag assembly is affixed to the port when the port opens. The sliding cutting element remains extended and heated to prevent contamination when the port is open. Further, a heating element is mounted about the window in order to sterilize around the opening when the port is open.

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: A lyophilization device configured for use in a lyophilization process has a body defining a chamber for receiving a liquid to be lyophilized, and a stopper creating a liquid-tight seal between the chamber and ambient atmosphere to form a sealed, empty sterile chamber. The stopper is adapted so that the chamber may be sterile filled with the substance through the stopper. A fluid passageway is formed through the stopper, through which the chamber is evacuated. The substance is lyophilized, the fluid passageway is closed, and the lyophilized substance is hermetically sealed within the chamber.

Abstract: A sterile enclosure contains a transfer module defining a window. A port covers the window to maintain the inside of the enclosure as a sealed and sterile environment. A sliding, heated cutting element mounted on the port serves to sterilize and sever a portion of a sterile transfer bag assembly attached to the port. Preferably, the excised portion of the sterile transfer bag assembly is affixed to the port when the port opens. The sliding cutting element remains extended and heated to prevent contamination when the port is open. Further, a heating element is mounted about the window in order to sterilize around the opening when the port is open.

Abstract: A dispenser for dispensing a substance has a variable-volume storage chamber for storing the product. A dispensing portion is coupled in fluid communication with the storage chamber for receiving substance therefrom, and an outlet aperture coupled in fluid communication with the bore. A one-way valve includes a valve seat and a flexible valve cover seated on the valve seat and defining a normally-closed 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 out of the dispenser. The dispenser further comprises a manually-engageable actuator for moving between first and second positions to dispense substance through the outlet aperture, and an integral, dome-shaped spring for biasing in a direction from one of the first and second positions toward the other.

Abstract: A container including a body defining an outflow opening and at least one chamber adapted for storing a product, such as a fat containing liquid product, and a container closure including a primary seal for hermetically sealing the product within the chamber during storage. The container closure includes a sealing member forming a substantially fluid-tight seal between the container closure and the body, and a dispensing member in fluid communication with the chamber. The container closure and body move relative to each other between a first position where the primary seal is seated about the outflow port to hermetically seal the product in the chamber during storage, and a second position where the primary seal is displaced from the outflow port to allow product to pass from the chamber through the outflow port and into dispensing member to dispense the product.

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.