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. A second filling member coupled in fluid communication with the second liquid source is placed in fluid communication with the storage chamber of the container located in the sterile filling chamber, and the second liquid component is aseptically introduced through the second filling member and into the storage chamber and, in turn, the first and second liquid components are combined into a liquid product formulation within the sterile chamber of the container. The first and second filling members are withdrawn from fluid communication with the storage chamber of the container located within the sterile filling chamber, and the filled storage chamber is sealed with respect to ambient atmosphere to hermetically seal the liquid product formulation within the storage chamber of the container.
Abstract:
Device and method 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 is pierceable with a needle to form a needle aperture therethrough to fill the chamber, and is laser resealable to hermetically seal the needle aperture by applying laser radiation. 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 during penetration by and withdrawal of the needle. The thermoplastic includes a predetermined amount of pigment that allows it to substantially absorb laser radiation at the 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:
An apparatus comprises a hermetically sealed, sterile storage chamber, a dispensing valve including a hermetically sealed, sterile inlet; a pump coupled between the dispensing valve and storage chamber; and a sealing surface located between the dispensing valve and storage chamber. The sealing surface and/or the dispensing valve is movable relative to the other between (i) a sealing position hermetically sealing the dispensing valve relative to the storage chamber to thereby prevent fluid flow therebetween, and (ii) a non-sealing position allowing fluid flow therebetween.
Abstract:
A dispenser for holding multiple doses of fluids or other substances, and for dispensing the substances, has a variable volume storage chamber. 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 dispensing valve is coupled in fluid communication with the storage chamber 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 fluid therethrough. The sealed, empty dispenser is sterilized, such as by applying gamma radiation thereto. Then, the sterilized, sealed, empty dispenser is filled with fluid by engaging the filling valve with a filling member and introducing fluid from the filling member through the filling valve and into the storage chamber. The fluid in the storage chamber is dispensed through the dispensing valve.
Abstract:
Disclosed is a uniquely configured medicament vial assembly which includes a storage vial, a stopper member and a securing ring. The vial assembly is configured to improve healthcare worker safety by providing a shielded gripping location to aid in the reduction of accidental needle sticks. The storage vial has a body portion which defines an interior chamber for storing a predetermined medicament and a neck portion through which medicament is received into and withdrawn from the interior chamber. The stopper member is inserted into the mouth of the vial and establishes a first seal. The securing ring is engaged with the mouth of the vial and adapted and configured for retaining the stopper member within the vial mouth and effectuating a second seal. The securing ring is formed from a thermoplastic and/or elastic material. Preferably, the securing ring is formed by molding the thermoplastic and/or elastic material over a portion of the storage vial and stopper member when engaged within the vial mouth.
Abstract:
An apparatus is provided for needle filling and thermally resealing containers having stoppers that are needle penetrable for filling the containers with a substance, and are thermally resealable for thermally sealing a needle hole in the stopper upon withdrawal of a needle therefrom. A container support of the apparatus supports at least one container having a resealable stopper in a substantially fixed position during needle filling and thermally resealing a needle hole in the stopper upon withdrawal of a needle therefrom. A manifold is drivingly mounted over the container support and comprises (1) a needle cartridge including a needle for penetrating the resealable stopper and introducing a substance through the needle and into the container, a needle mount for mounting the needle cartridge on the manifold, and a needle cover releasably coupled to the needle mount for covering the needle during transportation, installation and/or removal of the needle cartridge from the manifold, and that is removable from the needle cartridge upon mounting the needle cartridge to the manifold. The manifold further includes a thermal source for heating a needle penetrated region of the stopper and, in turn, sealing a needle hole in the stopper.
Abstract:
Apparatus is provided 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 stopper receivable within the opening for sealing the opening and substance received in the container. A barrier enclosure defines an aseptic chamber. A mold includes within the aseptic chamber plural mold cavities shaped to form the stopper 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 stopper is movable relative to the mold to engage and de-mold the substantially sterile stoppers and container bodies from the mold cavities. A source of sterile air is in fluid communication with the aseptic chamber and directs a flow of sterile air into the aseptic chamber and over the sterile surfaces of the mold for maintaining the sterility of the mold surfaces and stopper and container bodies during de-molding thereof. First flexible barriers are coupled to the mold between the sterile surfaces and the molding machine to substantially prevent the passage of contaminants from the molding machine therethrough. A second flexible barrier is coupled to the tool between the engaging portion and a base portion of the tool to substantially prevent the passage of contaminants from the base portion of the tool therethrough. A needle filling and thermal resealing station is configured to receive the sealed, empty sterile containers, needle fill the interior chambers of the containers, and thermally reseal resulting needle holes in the stoppers.
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. The thermoplastic includes a predetermined amount of pigment that allows the thermoplastic to substantially absorb laser radiation at the 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:
An apparatus has a valve body defining a first passageway, a valve seat, and a flow aperture extending through the valve body and coupled in fluid communication with the first passageway. A valve cover of the apparatus is formed of an elastic material and includes a cover base mounted on the valve body and fixedly secured against movement relative thereto, and a valve portion overlying the valve seat. The valve portion defines a predetermined radial thickness and forms an interference fit with the valve seat. The valve portion and the valve seat define a normally closed, axially-extending valve opening therebetween. The valve portion is movable between a normally closed position with the valve portion engaging the valve seat, and an open position with at least a segment of the valve portion spaced away from the valve seat to connect the valve opening in fluid communication with the flow aperture to thereby allow the passage of fluid from the flow aperture through the valve opening. A hermetically sealed variable-volume storage chamber stores therein multiple portions of the fluid and is connectible in fluid communication with the one-way valve assembly. A pump is coupled between the variable-volume storage chamber and the one-way valve assembly, and is configured to pump discrete portions of fluid from the variable-volume storage chamber, through the flow aperture, and through the valve opening to dispense the portions of fluid through the valve assembly.