Abstract: A device and method are provided for needle penetrating and filling a chamber with a predetermined substance, and laser resealing a resulting needle hole in the device. 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 through the needle, and is laser resealable to hermetically seal the needle aperture by applying laser radiation at a predetermined wavelength and power thereto. The needle penetrable and laser resealable portion defines a predetermined wall thickness in an axial direction thereof, and includes a thermoplastic that substantially prevents the formation of particles released into the chamber from the needle penetrable and laser resealable portion during penetration by and withdrawal of the needle.

Abstract: A vial has a body defining a chamber for receiving a substance therein; and a valve assembly coupled in fluid communication with the chamber and defining (i) an open position permitting at least one of (a) passage of the substance through the valve assembly and into the chamber for storing the substance in the chamber, and (b) passage of the substance out of the chamber for dispensing the substance therefrom; and (ii) a closed position forming a fluid-tight seal between the chamber and exterior of the container. A filling member is connectable in fluid communication with the valve assembly to fill the chamber therethrough.

Abstract: A sterile filling machine and related method are provided for sterile filling a container with a substance. The container includes a heat resealable stopper and a chamber for receiving the substance therein. The sealed, empty containers are subjected to radiation capable of penetrating through the stopper 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 needle is moved into engagement with the stopper to pierce the sterilized penetrable surface of the stopper and inject the substance through the needle and into the chamber of the container. Laser energy is then transmitted onto the penetrated surface of the stopper to fuse the stopper material and hermetically re-seal the stopper.

Abstract: Apparatus for molding and filling a device having a body defining an opening in communication with an interior chamber for receiving a substance therein, and a closure including a penetrable and resealable portion for sealing the opening and substance received in the device. A mold includes within the aseptic chamber plural mold cavities shaped to form the closure and body, and substantially sterile surfaces extending about and contiguous to the peripheries of the mold cavities. An assembly device including end-of-arm tooling having an engaging portion engageable with each of the body and closure is movable relative to the mold to engage and de-mold the substantially sterile closures and bodies from the mold cavities. Flexible barriers are coupled to the mold and the tool to substantially prevent the passage of contaminants from the molding machine and tool therethrough.

Abstract: A device defining a chamber for receiving a substance and a thermoplastic portion in fluid communication with the chamber is provided along with a method of filling and sealing the substance within the chamber. The thermoplastic portion defines a penetrable region that is penetrable by a filling member and is heat resealable to hermetically seal an aperture therein by applying laser radiation at a predetermined wavelength and power. The thermoplastic portion comprises a thermoplastic body defining a predetermined wall thickness and includes a styrene block copolymer, an olefin and a predetermined amount of pigment allowing the body to absorb laser radiation at the predetermined wavelength, substantially prevent the passage of radiation through the predetermined wall thickness, and hermetically seal the aperture in the penetrable region in a predetermined time period.

Abstract: A container comprising a container body defining a storage chamber for receiving a substance and a container closure removably attached to the container body for sealing the storage chamber. The container closure includes a base defining an aperture in fluid communication with the storage chamber, and a needle penetrable and thermally resealable stopper overlying the aperture for aseptically filling the storage chamber with the substance and sealing the substance within the storage chamber with respect to the ambient atmosphere. A sealing portion engages the container body prior to filling and forms a substantially dry hermetic seal between the container closure and container body. The container further comprises an over closure engageable with the container closure such that removal or movement of the over closure from a first position to a second position results in substantially simultaneous removal of the container closure and stopper to allow dispensing of the substance.

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 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 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: An apparatus and method are provided for formulating and aseptically filling liquid products. A first liquid source includes at least one first liquid component; a second liquid source includes at least one second liquid component; and a container includes a body defining an empty, sterile storage chamber therein that is sealed with respect to ambient atmosphere. The container is introduced into a sterile filling chamber. A first filling member coupled in fluid communication with the first liquid source is placed in fluid communication with the storage chamber of the container located in the sterile filling chamber, and the first liquid component is aseptically introduced through the first filling member and into the storage chamber.

Abstract: An apparatus and method are provided for formulating and aseptically filling liquid products. A first liquid source includes at least one first liquid component; a second liquid source includes at least one second liquid component; and a container includes a body defining an empty, sterile storage chamber therein that is sealed with respect to ambient atmosphere. The container is introduced into a sterile filling chamber. A first filling member coupled in fluid communication with the first liquid source is placed in fluid communication with the storage chamber of the container located in the sterile filling chamber, and the first liquid component is aseptically introduced through the first filling member and into the storage chamber.

Abstract: A device and method are provided for needle penetrating and filling a chamber with a predetermined substance, and laser resealing a resulting needle hole in the device. 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 through the needle, and is laser resealable to hermetically seal the needle aperture by applying laser radiation at a predetermined wavelength and power thereto. The needle penetrable and laser resealable portion defines a predetermined wall thickness in an axial direction thereof, and includes a thermoplastic that substantially prevents the formation of particles released into the chamber from the needle penetrable and laser resealable portion during penetration by and withdrawal of the needle.

Abstract: Apparatus for molding and filling a container having a container body defining an opening in communication with an interior chamber for receiving a substance therein, and a container closure including stopper receivable within the opening for sealing the opening and substance received in the container. A mold includes within the aseptic chamber plural mold cavities shaped to form the container closure and container body, and substantially sterile surfaces extending about and contiguous to the peripheries of the mold cavities. An assembly device including end-of-arm tooling having an engaging portion engageable with each of the container body and container closure is movable relative to the mold to engage and de-mold the substantially sterile container closure and container bodies from the mold cavities. Flexible barriers are coupled to the mold and the tool to substantially prevent the passage of contaminants from the molding machine and tool therethrough.

Abstract: A device defining a chamber for receiving a substance and a thermoplastic portion in fluid communication with the chamber is provided along with a method of filling and sealing the substance within the chamber. The thermoplastic portion defines a penetrable region that is penetrable by a filling member and is heat resealable to hermetically seal an aperture therein by applying laser radiation at a predetermined wavelength and power. The thermoplastic portion comprises a thermoplastic body defining a predetermined wall thickness and includes a styrene block copolymer, an olefin and a predetermined amount of pigment allowing the body to absorb laser radiation at the predetermined wavelength, substantially prevent the passage of radiation through the predetermined wall thickness, and hermetically seal the aperture in the penetrable region in a predetermined time period.