Abstract: A device and method for aseptically storing and dispensing a liquid. The device has container forming a variable-volume storage chamber, and a one-way valve coupled in fluid communication with the storage chamber and having an elastic valve member forming a normally closed valve opening. The valve member is movable between a normally closed position, and an open position with at least a segment of the elastic valve member spaced radially away from the closed position to allow the passage of fluid from the storage chamber through the valve opening. The liquid is maintained hermetically sealed in the storage chamber with respect to ambient atmosphere throughout dispensing multiple portions of the liquid from the storage chamber through the one-way valve.

Abstract: A dispenser has a housing, and a variable-volume storage chamber formed within the housing and defining a substantially fluid-tight seal between the chamber and exterior of the housing for storing a substance to be dispensed. A piston is mounted within the housing, and a one-way valve is mounted within the housing and coupled in fluid communication with the variable-volume storage chamber.

Abstract: A sterile filling machine and related method are provided for sterile filling a container with a substance. The container includes a resealable stopper or portion and a chamber for receiving the substance therein. The sealed, empty containers are subjected to radiation capable of penetrating through the resealable portion and chamber for sterilizing the container. The previously sterilized containers are then transported through another sterilizing chamber, such as an e-beam chamber, to sterilize the penetrable surface. A filling member is moved into engagement with the resealable portion to pierce the sterilized penetrable surface of the resealable portion and inject the substance through the filling member and into the chamber of the container. Energy is then transmitted onto the stopper to hermetically re-seal the penetration in the resealable portion.

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 device and related method are provided for lyophilizing a substance within the device and storing therein the lyophilized substance. The device is penetrable by a needle for filling the device with the substance to be lyophilized, and a resulting needle hole in the device is laser resealable by transmitting thereon laser radiation from a laser source. The device defines a chamber for receiving therein the substance to be lyophilized. A needle penetrable and laser resealable portion of the device is pierceable with a needle to form a needle aperture therethrough to fill the chamber with the substance to be lyophilized through the needle, and is laser resealable to hermetically seal the needle aperture by applying laser radiation thereto.

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 container and method are provided for storing fat containing liquid products. The container includes a body defining a storage chamber for receiving the product, and a container closure. A first material portion forms at least most of the surface area overlying the storage chamber that can contact any product therein. Neither the body nor the first material portion leach more than a predetermined amount of leachables into the product or undesirably alter a taste profile thereof. A needle penetrable and thermally resealable second material portion either (i) overlies the first material portion and cannot contact any product within the storage chamber, or (ii) forms a substantially lesser surface area overlying the storage chamber that can contact any product therein in comparison to the first material portion. A sealing portion is engageable with the body to form a substantially dry hermetic seal between the container closure and body.

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 container also includes a base, a mid-portion, and an upper portion axially spaced from the base on an opposite side of the mid-portion relative to the base. Each of the base and upper portion define a laterally-extending dimension greater than a maximum laterally-extending dimension of the mid-portion. The 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 while engaging the base of the body to substantially prevent upward movement of the body, and applying energy to the penetrable and resealable portion to form a gas-tight seal.

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 has a housing, and a variable-volume storage chamber formed within the housing and defining a substantially fluid-tight seal between the chamber and exterior of the housing for storing a substance to be dispensed. A piston is mounted within the housing, and a one-way valve is mounted within the housing and coupled in fluid communication with the variable-volume storage chamber.