Apparatuses and Methods for Formulating Using a Swirl Chamber

An outer shell and nozzle portion define therebetween a swirl chamber having a plurality of inlet flow paths and an outlet flow path. The swirl chamber may receive a plurality of substances or components from separate sources, to mix the plurality of substances in the swirl chamber, and to deliver the mixed substances or formulation through an outlet, e.g., to a connector. The substances may be sterile, and the entire flow path from the substance sources to the container may be sterile and aseptically sealed from ambient atmosphere. The outer shell and nozzle portion may be constructed of plastic or other disposable materials. The swirl chamber may be constructed to optimize the mixing of the substances through control of the velocity by which each substance enters the swirl chamber. 1. An apparatus for mixing comprising:a body including a swirl chamber therein, at least two inlet flow paths in fluid communication with the swirl chamber for delivering substance into the swirl chamber, and an outlet aperture in fluid communication with the swirl chamber for substance to pass out of the swirl chamber;wherein at least one of the at least two inlet flow paths is in fluid communication with a first substance and at least one of the at least two inlet flow paths is in fluid communication with a second substance that is different than the first substance so that the first substance and the second substance entering the swirl chamber are mixed in the swirl chamber, and a resulting mixture exits the swirl chamber through the outlet aperture.2. The apparatus of claim 1 , wherein the body includesa nozzle portion defining said outlet aperture; andan outer shell positioned over and engaged with the nozzle portion;the nozzle portion and the outer shell defining therebetween the swirl chamber and at least part of the at least two inlet flow paths.3. The apparatus of claim 2 , wherein each of the at least two inlet flow paths are defined at least in part by a recess in the outer ...

Aseptic connector with deflectable ring of concern and method

An aseptic fluid connector having a first connector including a first fluid passageway for receiving a fluid therein; a first port in fluid communication with the first fluid passageway for passage of the fluid therethrough; and a first deflecting member. The first deflecting member includes a first engaging portion radially spaced relative to the first port, and a first valve movable between a closed position and an open position with movement of the first engaging portion between a non-deflected position and a deflected position, respectively. In the non-deflected position, the first valve is located in the closed position forming a fluid-tight seal between the first valve and first port and preventing the passage of fluid therethrough, and in the deflected position, the first valve is located in the open position allowing the aseptic passage of fluid through the first port.

Septum that decontaminates by interaction with penetrating element

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.

SEPTUM THAT DECONTAMINATES BY INTERACTION WITH PENETRATING ELEMENT

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. 1. A septum comprising:a peripheral portion extending about a periphery of the septum, an exterior surface located on an external side of the septum, and an interior surface located on an opposite side of the septum;a penetration portion penetrable by a needle or other penetrating element extending between the exterior and interior surfaces that is spaced inwardly of the peripheral portion and is penetrable by the needle or other penetrating element;a flex portion located between the penetration portion and the peripheral portion; andan increased thickness portion extending between the flex portion and the penetration portion, and defining an increased thickness between the exterior and interior surfaces relative to the flex portion, wherein the flex portion is flexible inwardly relative to the peripheral portion during penetration of the penetration portion by a needle or other penetrating element, and the penetration portion physically interacts with and decontaminates the needle or other ...

Fluid dispenser having a one-way valve, pump, variable-volume storage chamber, and a needle penetrable and laser resealable portion

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.

APPARATUS AND METHOD FOR FILLING AND RESEALING

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. 1. An apparatus for filling and resealing devices having penetrable regions that are penetrable for filling the devices with a substance , and are resealable for sealing a hole formed therein upon withdrawal of a filling member therefrom , the apparatus comprising:a device support movable between a plurality of positions and configured to support at least one device having a penetrable region in a substantially fixed position during one or more of filling or resealing a hole in the penetrable region formed upon withdrawal of a filling member therefrom;a manifold drivingly mounted over the device support when the device support is in at least one of the plurality of positions, and comprising at least one filling member configured to penetrate a penetrable region of a device and introducing a substance through the at least one filling member and into said device; andat least one resealing apparatus configured to reseal a hole in said penetrable region formed by the at least one filling member.2. An apparatus as defined in claim 1 , wherein the at least one resealing apparatus includes an output for transmitting a laser beam therefrom and onto a penetrated region ...

Container and valve assembly for storing and dispensing substances, and related method

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.

DEVICE WITH SLIDING STOPPER AND RELATED METHOD

A device that has a device body defining an opening at one end thereof, a storage chamber within the device body for storing multiple doses of a substance therein, and a sliding stopper, sealing engageable with the device body, through which the chamber is filled. The stopper has a body and a flexible portion, which may be in the form of a plurality of flexible members, extending therefrom. The flexible portion or members are movable between first and second positions. In the first position, during filling, the portion or members are substantially laterally extending from the stopper body and engaging the opening of the device body. Accordingly, the axial position of the stopper with respect to the device body is secured during filling of the chamber therethrough. In the second position, after filling, the portion or members are substantially axially-extending from the stopper body and disengaged from the rim or opening of the device body. Accordingly, the stopper is axially slideable through the body. 1. A device for storing a substance to be dispensed , comprising:a device body defining an opening at one end thereof;a storage chamber within the device body for storing a substance therein; anda sliding stopper, sealingly engageable within the device body, having a stopper body adapted for filling the substance into the storage chamber therethrough and a flexible portion or a plurality of flexible members extending from the stopper body, wherein the flexible portion or members are movable between (i) a first position, wherein the flexible portion or members are substantially laterally extending from the stopper body and engaging the opening of the device body, thereby securing the axial position of the stopper with respect to the device body during filling of the chamber therethrough, and (ii) a second position, wherein the flexible portion or members are substantially axially-extending from the stopper body and substantially disengaged from the opening of the ...

Device with closure including base with valve seat and support with valve member, penetrable portion and actuator

A device comprises a first portion including a first polymer, and a second portion that is relatively flexible in comparison to the first portion and includes a second polymer that is substantially not bondable to the first polymer. A chamber of the device is hermetically sealable with respect to ambient atmosphere and is defined by (i) an interior of the second portion, and/or (ii) a space formed between the first and second portions. A third portion of the device includes a third polymer that is bondable to the first and second polymers and fixedly secures the first and second portions to each other.

Device with one-way valve

A dispenser for dispensing a substance, such as a liquid lipstick or other cosmetic, pharmaceutical or cosmeceutical product, has a body with a variable-volume storage chamber for storing the product. A dispensing portion is connected with the body and a one-way valve for dispensing amounts of product therethrough. The dispensing portion defines a compression chamber in fluid communication with the storage chamber for receiving product therefrom, and an outlet aperture coupled in fluid communication with the compression chamber. The one-way valve has a valve seat, and a visco-elastic valve cover seated on the valve seat and defining a normally-closed, axially-extending seam therebetween forming a fluid-tight seal between the valve cover and valve seat. The flexible valve cover is movable relative to the valve seat, and the seam is connectable in fluid communication with the outlet aperture to allow the passage of product through the seam and out of the dispenser. An actuator is drivingly ...

Dispenser and method for storing and dispensing sterile product

A dispenser is provided for the delivery of controlled, metered amounts of any of numerous different substances to humans or animals, such as medicaments, pharmaceuticals, cosmetics, and food products, or to deliver materials that may react upon exposure to air, such as glue. Means are provided in the dispenser to effect controlled delivery of a pre-determined amount of the substance contained in the dispenser. A one-way valve is provided to hermetically seal the portion of the dispenser containing the substance to be dispensed.

Laterally-actuated dispenser with one-way valve for storing and dispensing substances

A dispenser has a body with a variable-volume storage chamber for storing product. A compression chamber is in fluid communication with the storage chamber for receiving substance therefrom. A one-way valve of the dispenser includes valve seat and flexible valve cover seated on the valve seat and defining a normally-closed seam therebetween forming a 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 through the seam and out of the dispenser. A manually-engageable actuator connected to the dispensing portion is movable between first and second positions to dispense substance within the compression chamber out of the dispenser.

Dispensing machine valve and method

A one-way valve is connectable in fluid communication with a fluid-receiving chamber, such as a dilution chamber or a mixing chamber for diluting or mixing a perishable food product, such as a milk product or chocolate product, and forming a substantially fluid-tight seal therebetween. The valve comprises a relatively rigid valve seat, and a relatively flexible valve member overlying the valve seat and forming an axially-elongated, normally-closed valve opening therebetween defining an inlet at one end of the valve seat, an outlet at an opposite end of the valve seat, and an axially-extending seal therebetween that forms a fluid-tight seal between the inlet and outlet of the normally-closed valve opening. An axially-extending valve body is radially spaced relative to the valve member and forms a space therebetween allowing fluid-flow therethrough for cleaning the valve and the fluid-receiving chamber. A seal is engageable with the fluid-receiving chamber and forms a substantially fluid-tight ...

CONTAINER AND VALVE ASSEMBLY FOR STORING AND DISPENSING SUBSTANCES, AND RELATED METHOD

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. 125-. (canceled)26. A method comprising:aseptically storing substance in an assembly including an internally sterile variable-volume storage chamber, and a one-way valve coupled in fluid communication with the variable-volume storage chamber and including an elastic valve member forming a normally closed valve opening, wherein the valve member is movable between a normally closed position, and an open position with at least a segment of the valve member spaced away from the closed position to allow the passage of substance from the variable-volume storage chamber through the valve opening; the storing step including(i) sterile filling the variable-volume storage chamber with a sterile substance; and(ii) hermetically and sterilely sealing the substance within the variable-volume storage chamber.27. A method as defined in claim 26 , further comprising the steps of:(iii) dispensing a plurality of different portions of the substance at different points in time from the variable-volume storage chamber through the one-way valve; and(iv) maintaining the substance within the variable-volume storage chamber sterile and hermetically sealed with respect to ambient atmosphere throughout steps (iii) and (iv).28. A method as ...

Apparatus and method for filling and resealing

Apparatus for filling containers having stoppers that are penetrable for filling the containers with a substance, and thermally resealable for thermally sealing the resulting hole. A container support supports at least one such container in a substantially fixed position during filling and resealing. A manifold drivingly mounted over the container support comprises (1) a cartridge including a filling needle for penetrating the resealable stopper and introducing a substance therethrough into the container, 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 includes a thermal source for heating a penetrated region of the stopper and, sealing the hole.

Sealed containers and methods of filling and resealing same

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.

Pouch connector and related method

A pouch connector includes a safety cap having a cap base portion and a main connector disposed opposite the safety cap. The main connector and safety cap are configured to receive a portion of a pouch therebetween. The main connector includes a piercing member for piercing the pouch, an actuating portion for actuating the piercing member and a main connector base portion. The piercing member is configured to pierce through a portion of the pouch so as to provide fluid communication between a substance inside the pouch and the interior of the main connector. A polymeric membrane is coupled to at least one of the cap base portion and the main connector base portion.

CONTAINERS WITH PENETRABLE AND RESEALABLE PORTION, AND RELATED METHODS

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. 1. An apparatus comprising:a container including a body defining a chamber for receiving a product;a container closure including a sealing portion forming a substantially fluid-tight seal between the container closure and the body, and a nipple, wherein the container closure seals the chamber with respect to the ambient atmosphere during storage of the product in the chamber and can be opened to dispense product from the chamber through the nipple; anda penetrable and resealable portion that is penetrable by an injection member for aseptically filling the chamber with the product through the injection member, and a resulting penetration hole is resealable to seal the product within the chamber.2. An apparatus as defined in claim 1 , wherein the nipple includes a sealing member that is movable between a first position sealing the nipple claim 1 , and a second position opening the nipple and allowing product in the chamber to be dispensed therethrough.3. An apparatus as defined in claim 2 , wherein the sealing member is frangibly connected to the nipple such that in the first position the sealing member is connected to ...

Sealed container and method of making and filling same

The invention relates to a sealed container and a method of making and filling the same. A medicament vial assembly 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 ...

Laterally-actuated dispenser with one-way valve for storing and dispensing metered amounts of substances

A dispenser for dispensing a substance, comprises: a body defining a variable-volume storage chamber for storing the substance; a dispensing portion connected with the body and defining a bore 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 including an axially-extending valve seat and an axially-extending flexible valve cover seated on the valve seat and defining a normally-closed, axially-extending seam therebetween forming a fluid-tight seal between the valve cover and valve seat, wherein the flexible valve cover is movable relative to the valve seat and the seam is connectable in fluid communication with the outlet aperture to allow the passage of substance through the seam and out of the dispenser; and an actuator and piston assembly including a piston receivable within the bore, a manually-engageable actuator connected to the piston for moving the piston ...

CONTROLLED NON-CLASSIFIED FILLING DEVICE AND METHOD

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. 1. An apparatus comprising:a housing at least partially defining a processing space;a device support for releasably holding a sealed device defining a sealed chamber for storing a substance therein, and a penetrable portion in fluid communication with the chamber and penetrable by a filling or injection member;a conveyor defining a path for transporting the support and the device along the path and through the processing space; and a de-contamination station located on the conveyor path and configured to de-contaminate at least the penetrable surface of the penetrable septum;', 'a filling station located on the conveyor path downstream of the de-contamination station and including at least one filling or injection member coupled or connectable in fluid communication with a source of substance to be filled into the chamber of the device, wherein one or more of (i) the filling or injection member or (ii) the device is movable relative to the other within the filling station to penetrate the penetrable septum with the filling or injection member, introduce substance through ...

Adjustable filling and sealing method and apparatus therefor

An assembly includes a support and drive assembly, a first structure and a second structure. The first structure is in operable communication with and supported by the support and drive assembly. The first structure includes at least one filling or needle assembly and is adjustable to receive a plurality of filling or needle assemblies. The second structure is supported by the support and drive assembly. The second structure includes at least one seal assembly and is adjustable to receive a plurality of seal assemblies. A method includes determining a number of containers or vials that are to be filled concurrently and adjusting an assembly to include at least one filling or needle assembly and at least one seal assembly. A number of the filling or needle assemblies and the seal assemblies equals the number of containers or vials.

Controlled non-classified filling device and method

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.

POUCH WITH FITMENT AND METHOD OF MAKING SAME

A sealed, empty pouch, wherein the interior of the pouch is particle and pyrogen free, is made by (i) molding a tubular film including an inner surface and an outer surface, and blowing or otherwise directing micro-filtered air and/or other gas through the tubular film during molding; (ii) flattening the molded tubular film; (iii) sealing the flattened tubular film at spaced locations, cutting the sealed film at the spaced locations, and forming a plurality of empty pouches; (iv) over-molding a fitment to the outer surface of each of a plurality of empty pouches and forming a fluid-tight seal between the fitment and the interior of the pouch; and (v) preventing the collection of particles on the inner surface of each pouch, and the exposure of each such inner surface to an ambient atmosphere throughout steps (i) through (iv). 1. A method comprising the following steps:(i) molding a tubular film including an inner surface and an outer surface, and blowing or otherwise directing micro-filtered air and/or other gas through the tubular film during molding;(ii) flattening the molded tubular film;(iii) sealing the flattened tubular film at spaced locations, cutting the film, and forming at least one empty pouch;(iv) over-molding a fitment to the empty pouch and forming a fluid-tight seal between the fitment and pouch; and(v) preventing the collection of one or more of particles or pyrogens on the inner surface of the pouch, and the exposure of the inner surface to an ambient atmosphere throughout steps (i) through (iv).2. A method as defined in claim 1 , wherein the molding includes blown film extrusion molding or blown film co-extrusion molding the tubular film claim 1 , and blowing or otherwise introducing a flow of micro-filtered air and/or other gas through the interior of an extrusion head and the tubular film.3. A method as defined in claim 1 , wherein at least an inner surface of the tubular film is at bactericidal or sterilization temperature during step (i).4. A ...

SINGLE USE CONNECTORS

Connector assembly including a piercing member having a flow port therein attached to a first piece, with the piercing member slidingly receivable within a second piece, wherein the piercing member and the second pierce are movable relative to each other between a first position where the second pieces closes the flow port and a second position where the flow port is open. The first piece contains a locking mechanism that lockingly engages with a device when connected thereto, preventing subsequent disconnection of first piece and the device. Upon initial connection of the first piece to the device, the second piece is moved from the first position to the second position. 1. A connector comprising:a first piece;a piercing member attached to the first piece; anda second piece, the piercing member being slidingly receivable within the second piece;wherein the piercing member and the second pierce are movable relative to each other between a first position where the second pieces closes a flow port and a second position where the flow port is open;the first piece further including a locking mechanism adapted to lockingly connect the first piece to a device when engaged therewith, thereby preventing subsequent disconnection of the first piece and the device.2. A connector as defined in claim 1 , wherein claim 1 , upon said engagement of the first piece and the device claim 1 , the second piece is moved from the first position to the second position.3. A connector as defined in claim 1 , wherein the locking mechanism comprises an inward lip on the first piece.4. A connector as defined in claim 3 , wherein the inward lip is adapted to engage an outward lip on the device after the outward lip slides past the inward lip.5. A connector as defined in claim 4 , wherein the first piece comprises an inner surface and the second piece comprises a stop surface that makes contact with the inner surface to stop the piercing member from further axial movement relative to the device ...

Co-extrusion blow molding apparatus and method, and sealed empty devices

A device comprising a body including a first polymer and a closure including a second polymer that is substantially not bondable to the first polymer and has a relatively higher shrinkage rate than the first polymer, wherein at least a portion of the closure overlaps at least a portion of the body, forming a hermetic seal there between and defining a sealed, empty, sterile container.

Device with sliding stopper and related method

A device that has a device body defining an opening at one end thereof, a storage chamber within the device body for storing multiple doses of a substance therein, and a sliding stopper, sealing engageable with the device body, through which the chamber is filled. The stopper has a body and a flexible portion, which may be in the form of a plurality of flexible members, extending therefrom. The flexible portion or members are movable between first and second positions. In the first position, during filling, the portion or members are substantially laterally extending from the stopper body and engaging the opening of the device body. Accordingly, the axial position of the stopper with respect to the device body is secured during filling of the chamber therethrough. In the second position, after filling, the portion or members are substantially axially-extending from the stopper body and disengaged from the rim or opening of the device body. Accordingly, the stopper is axially slideable through ...

One-way valve and apparatus and method of using the valve

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.

DEVICE CONTAINING FIRST, SECOND AND THIRD POLYMERS

A device that includes a first portion including a first polymer, a second portion including a second polymer, and a third portion defining a third polymer. The second polymer is substantially not bondable to the first polymer, and the third polymer is bondable to the first polymer and fixedly secures the first portion to the second portion. A device that includes a body and a closure and including and a first polymer, a second polymer and a third polymer, wherein the first polymer is bondable with the second polymer, and the third polymer is substantially not bondable to the first polymer. 1. A device comprising:a first portion including a first polymer;a second portion including a second polymer; anda third portion defining a third polymer;wherein the second polymer is substantially not bondable to the first polymer, and the third polymer is bondable to the first polymer and fixedly secures the first portion to the second portion.2. The device of claim 1 , wherein the third polymer is bondable to the second polymer.3. The device of claim 2 , wherein the third portion is bonded to the second portion.4. The device of claim 1 , wherein the device defines a closure portion including a penetrable and resealable septum.5. The device of claim 4 , wherein the device defines a storage chamber therein claim 4 , and the closure hermetically seals the storage chamber from ambient atmosphere.6. The device of claim 5 , wherein the storage chamber contains a substance therein.7. The device of claim 6 , wherein the substance is aseptic or sterile.8. The device of claim 5 , wherein the storage chamber defines a variable volume storage chamber.9. The device of claim 5 , wherein the device further defines a pump and a one-way valve placeable in fluid communication with the storage chamber to dispense substance from the storage chamber through the one-way valve and out of the device.10. The device of claim 9 , wherein the storage chamber contains an aseptic or sterile substance claim ...

Method for dispensing ophthalmic fluid

An ophthalmic dispenser and method of filling and dispensing fluid stored therein. The dispenser includes a rigid housing defining a fluid-receiving chamber, a flexible bladder receivable within the fluid-receiving chamber, a pump coupled in fluid communication with the fluid-receiving chamber, and a nozzle having a valve defining an annular, axially-extending valve seat, an outlet aperture coupled in fluid communication between the valve seat and the pump, and a flexible valve cover extending about the valve seat and forming an annular, axially-extending interface therebetween. The valve interface is connectable in fluid communication with the outlet aperture, and at least part of the valve cover is movable between (i) a normally closed position with the valve cover engaging the valve seat to close the interface and form a fluid-tight seal therebetween, and (ii) an open position with at least part of the valve cover spaced away from the valve seat in response to pumped fluid flowing through ...

Aseptic connector with deflectable ring of concern and method

An aseptic fluid connector having a first connector including a first fluid passageway for receiving a fluid therein; a first port in fluid communication with the first fluid passageway for passage of the fluid therethrough; and a first deflecting member. The first deflecting member includes a first engaging portion radially spaced relative to the first port, and a first valve movable between a closed position and an open position with movement of the first engaging portion between a non-deflected position and a deflected position, respectively, in the non- deflected position, the first valve is located in the closed position forming a fluid-tight seal between the first valve and first port and preventing the passage of fluid therethrough, and in the deflected position, the first valve is located in the open position allowing the aseptic passage of fluid through the first port.

Device with co-extruded body and flexible inner bladder and related apparatus and method

A device comprises a first portion including a first polymer, and a second portion that is relatively flexible in comparison to the first portion and includes a second polymer that is substantially not bondable to the first polymer. A chamber of the device is hermetically sealable with respect to ambient atmosphere and is defined by (i) an interior of the second portion, and/or (ii) a space formed between the first and second portions. A third portion of the device includes a third polymer that is bondable to the first and second polymers and fixedly secures the first and second portions to each other.

DEVICES AND METHODS FOR FORMULATION PROCESSING

Apparatuses and methods for controlling transfer of substances to a formulation container to provide a predetermined formulation. A controller may utilize one or more of a flow time, flow rate or a volume of transfer of substance. Barcoded and RFID-containing components may be used to determine what connection or disconnection has been made, and/or time thereof. Process compliance may compare measured or determined flow or connection time, flow rate and/or the transfer volume to a predetermined time, flow rate and/or volume, and adjust one or more of the time, flow rate and/or the volume of the transfer. An optional holder or cradle is configured to receive therein a fluid transfer connector formed by the connection of first and second connector portions, each in fluid communication with a flow conduit or channel that delivers substance to or receives substance from its respective connector portion, only if the connector portions are properly connected together. One or more sensors may be used to determine identification information of the connector and/or flow rates of substance through the connector.

Dispensing machine valve and method

A one-way valve is connectable in fluid communication with a fluid-receiving chamber, such as a dilution chamber or a mixing chamber for diluting or mixing a perishable food product, such as a milk product or chocolate product, and forming a substantially fluid-tight seal therebetween. The valve comprises a relatively rigid valve seat, and a relatively flexible valve member overlying the valve seat and forming an axially-elongated, normally-closed valve opening therebetween defining an inlet at one end of the valve seat, an outlet at an opposite end of the valve seat, and an axially-extending seal therebetween that forms a fluid-tight seal between the inlet and outlet of the normally-closed valve opening. An axially-extending valve body is radially spaced relative to the valve member and forms a space therebetween allowing fluid-flow therethrough for cleaning the valve and the fluid-receiving chamber.

Co-extrusion blow molding apparatus and method, and sealed empty devices

A device comprising a body including a first polymer and a closure including a second polymer that is substantially not bondable to the first polymer and has a relatively higher shrinkage rate than the first polymer, wherein at least a portion of the closure overlaps at least a portion of the body, forming a hermetic seal therebetween and defining a sealed, empty, sterile container.

Device with closure, one-way valve, and storage chamber and related method

A device has a first part with a valve seat and storage chamber, and a second part with a flexible valve cover and actuator. The storage chamber may be formed from a pre-form blow-molded into a flexible pouch defining a variable-volume storage chamber. The flexible valve cover and valve seat form a normally closed valve seam therebetween. The valve cover is movable in response to fluid at an inlet to the seam exceeding a valve opening pressure of the one-way valve between (i) a normally closed position with valve cover and valve seat in contact with each other and defining the normally closed seam, and (ii) a second position with at least a portion of the valve cover spaced away from the valve seat to allow the fluid to pass through the seam. The one-way valve may have anti-spritz features for using the device to dispense a substance, such as to the eye. The device may contain prostaglandins without the device material absorbing the prostaglandins material and/or without the material being ...

Multiple dose vial and method

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 variable-volume storage chamber within the body for storing multiple doses of the substance therein, 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 variable-volume 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.

Delivery device with separate chambers connectable in fluid communication when ready for use, and related method

A device and method are provided for storing substances separately, and for mixing the substances prior to use. The device defines at least one first chamber for receiving a first substance, and at least one second chamber for receiving a second substance. A first sealing portion is located between the first and second chambers and is movable between a closed position preventing fluid communication between the chambers, and an open position permitting fluid communication between the first and second chambers for mixing the substances. First and second penetrable and resealable portions in fluid communication with the first and second chamber(s), respectively, may be used for filling by penetrating them with an injection member and introduce the substances therethrough and into the respective chamber, and resealing the injection apertures and the substances within the respective chamber.

Device with penetrable and resealable portion and related method

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.

Sterile Filling Machine Having Filling Station and E-Beam Chamber

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. 1. A method comprising the following steps:providing a plurality of devices, wherein each device includes a penetrable and resealable portion, and a sealed empty chamber in fluid communication with the penetrable and resealable portion;sterilizing the plurality of sealed, empty devices by subjecting them to radiation capable of penetrating through the penetrable and resealable portions and into the chambers;transporting the plurality of devices with sterilized internal chambers on a conveyor;conveying the devices through a sterilizing station and sterilizing at least an external surface of the penetrable and resealable portions of the devices;introducing at least one injection member through the penetrable and resealable portions of the devices;introducing through the at least one injection member a sterile substance into the sterile chambers of the devices;withdrawing the at least one injection member from the penetrable and resealable portions; andresealing the penetrable and resealable portions and sealing the sterile substance within the devices.2. A method as defined in claim 1 , further comprising moving the ...

Dispenser with Variable-Volume Storage Chamber, One-Way Valve, and Manually-Depressible Actuator

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. A compression chamber is coupled in fluid communication between the piston and one-way valve, and at least one of the piston and valve is manually depressible relative to the other between (i) a first position in which the piston is located at least partially outside of the compression chamber for permitting substance to flow from the variable-volume storage chamber into the compression chamber, and (ii) a second position in which the piston is located at least partially within the compression chamber for pressurizing substance within the compression chamber above a valve opening pressure and, in turn, dispensing substance through the one-way valve and out of the dispenser.

Sterile De-Molding Apparatus and Method

At least one of first and second mold portions defines a mold cavity to receive molten plastic and form therefrom at least one molded part, and is movable relative to the other between (i) a closed position for sealing the mold cavity or cavities and molding at least one part therein, and (ii) an open position defining a fluid passageway between the mold portions and permitting the passage of a fluid sterilant therein. A fluid sterilant source is connectable in fluid communication with the fluid passageway for introducing the sterilant therein in the open position, contacting with the sterilant the surfaces of the first and second mold portions forming the fluid passageway and located adjacent to the at least one mold cavity, but not contacting an interior surface of a molded part within the mold cavity, to sterilize the exposed mold surfaces and thereby prevent contamination of the molded part. 1. An apparatus for molding sterile parts , the apparatus comprising:a first mold portion and a second mold portion, wherein at least one of the first and second mold portions defines a mold cavity configured to receive a molten plastic and form therefrom at least one molded part, and at least one of the first and second mold portions is movable relative to the other between a closed position for sealing the at least one mold cavity and molding the at least one molded part therein, and an at least partially open position defining a fluid passageway between the first and second mold portions and permitting the passage of a fluid therein; anda fluid source containing a fluid sterilant that is connectable in fluid communication with the fluid passageway and adapted for introducing the fluid sterilant into the fluid passageway in the at least partially open position, and in turn, contacting with the fluid sterilant at least one surface of the first and second mold portions located adjacent to the at least one mold cavity, but not in contact with an interior surface of a molded ...

Pouch Connector and Related Method

A pouch connector includes a safety cap having a cap base portion and a main connector disposed opposite the safety cap. The main connector and safety cap are configured to receive a portion of a pouch therebetween. The main connector includes a piercing member for piercing the pouch, an actuating portion for actuating the piercing member and a main connector base portion. The piercing member is configured to pierce through a portion of the pouch so as to provide fluid communication between a substance inside the pouch and the interior of the main connector. A polymeric membrane is coupled to at least one of the cap base portion and the main connector base portion. 1. A connector for a pouch defining a storage chamber , the connector comprisinga housing including a piercing member hermetically sealed within the housing and movable between (i) a disengaged position wherein the piercing member is not piercing the pouch, and (ii) an engaged position wherein the piercing member is piercing the pouch and is in fluid communication with the storage chamber of the pouch, and a first pouch-engaging surface engageable with a first side of the pouch and forming a hermetic seal therebetween; anda stop member including a second pouch-engaging surface engageable with a second side of the pouch opposite the first side of the pouch, and a stop surface.2. A pouch connector as defined in claim 1 , wherein the stop surface stops the piercing member in the engaged position.3. A pouch connector as defined in claim 1 , wherein the stop member is coupled to the housing claim 1 , and at least one of the stop member and housing is movable relative to the other.4. A pouch connector as defined in claim 3 , further including a hinge connected between the stop member and the housing.5. A pouch connector as defined in claim 4 , wherein the stop member and housing are formed integral with each other claim 4 , and the hinge is a living hinge extending between the stop member and housing.6. A pouch ...

READY TO FEED CONTAINER AND METHOD

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. 1. A container for storing and dispensing a product , the container comprising:a body defining a chamber for storing the product and an outflow port periphery defining an outflow port in fluid communication with the chamber; and a primary seal;', 'a secondary seal forming a substantially fluid-tight seal between the container closure and the body; and', 'a dispensing member defining an outlet aperture in fluid communication with the body;, 'a container closure includingwherein at least one of the container closure and body is movable relative to the other between a first position where the primary seal at least one of i) extends into the outflow port in a direction toward the chamber and sealingly engages a surface of the outflow port periphery that is internal to the outflow port and ii) sealingly engages a surface of the outflow port periphery that is external to the outflow port and extends along said surface in a direction toward the chamber to hermetically seal the product in the chamber, and a second position where the primary seal is displaced from the outflow port to place the dispensing member in ...

Container Closure with Overlying Needle Penetrable and Resealable Portion and Underlying Portion Compatible with Fat Containing Liquid Product, and Related Method

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.

One-Way Valve and Apparatus and Method of Using the Valve

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. 1. A flexible pouch and valve assembly 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 , wherein the flexible pouch and valve assembly are receivable within a relatively rigid housing and 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 comprising: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; anda one-way valve including a valve body defining an axially-extending valve seat and at least one flow aperture extending through at least one of the valve body and valve seat; and a valve cover mounted on the valve body, and including an axially-extending portion formed of an elastic material, overlying the valve seat and covering a substantial axially-extending ...

Method for Molding and Assembling Containers with Stoppers and Filling Same

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. 125-. (canceled)26. A resealable member comprising:a penetrable region defining a predetermined wall thickness that is penetrable by a filling member and is laser resealable to hermetically seal an aperture therein by applying laser radiation from a laser source at a predetermined wavelength and power thereto;wherein the penetrable region defines a predetermined color and opacity that absorbs the laser radiation at the predetermined wavelength and causes the laser radiation at the predetermined wavelength and power to seal the aperture in the penetrable region thereof in a predetermined time period;wherein the color and opacity is defined by a colorant or pigment at a predetermined concentration;whereby the laser radiation at least one of (a) seals the aperture to a substantially predetermined depth of at least one of the wall thickness and the aperture and (b) raises a surface temperature of the penetrable portion to a substantially predetermined temperature.27. A resealable member as defined in claim 26 , wherein at least one of the power and the concentration are selected so that the laser radiation seals the aperture to the determined depth.28. A resealable member as defined in claim 26 , wherein the predetermined depth provides the penetrable region with sufficient integrity after sealing to not ...

Multiple Dose Delivery Device with Manually Depressible Actuator and One-Way Valve for Storing and Dispensing Substances, and Related Method

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.

Dispenser and Method for Storing and Dispensing Sterile Product

A dispenser is provided for the delivery of controlled, metered amounts of any of numerous different substances to humans or animals, such as medicaments, pharmaceuticals, cosmetics, and food products, or to deliver materials that may react upon exposure to air, such as glue. Means are provided in the dispenser to effect controlled delivery of a pre-determined amount of the substance contained in the dispenser. A one-way valve is provided to hermetically seal the portion of the dispenser containing the substance to be dispensed. 133-. (canceled)34. A device for aseptically receiving and dispensing fluid comprising:a sterile chamber having a sealed inlet at one end thereof for receiving fluid into the chamber, defined by a resealable member, and an outlet for dispensing fluid out of the chamber;wherein the resealable member is penetrable by an injection member for introducing substance through the resealable member and into the chamber, and is resealable to form a gas-tight seal between the chamber and at least one of the ambient atmosphere and a penetrated region of the resealable member after withdrawing the injection member therefrom.35. A device as define in claim 34 , wherein the penetrable and resealable member comprises a resilient polymeric material.36. A device as defined in claim 34 , wherein fluid within the chamber is sealed with respect to ambient atmosphere during dispensing of said fluid through the outlet of the device.37. A device as defined in claim 34 , further comprising a first portion defining at least a portion of the chamber and the outlet of the chamber claim 34 , and a second portion defining a hollow passage therein for the passage of fluid therethrough claim 34 , and claim 34 , in turn claim 34 , through the resealable member and into the chamber claim 34 , wherein the first and second portions are engageable with one another for receiving fluid into the chamber and dispensing said fluid therefrom.38. A device as defined in claim 37 , ...

Dispenser with One-Way Valve for Storing and Dispensing Substances

A dispenser for dispensing a substance, such as a liquid lipstick or other cosmetic, pharmaceutical or cosmeceutical product, has a body with a variable-volume storage chamber for storing the product. A dispensing portion is connected with the body and a one-way valve for dispensing amounts of product therethrough. The dispensing portion defines a compression chamber in fluid communication with the storage chamber for receiving product therefrom, and an outlet aperture coupled in fluid communication with the compression chamber. The one-way valve has a valve seat, and a visco-elastic valve cover seated on the valve seat and defining a normally-closed, axially-extending seam therebetween forming a fluid-tight seal between the valve cover and valve seat. The flexible valve cover is movable relative to the valve seat, and the seam is connectable in fluid communication with the outlet aperture to allow the passage of product through the seam and out of the dispenser. An actuator is drivingly connected to the compression chamber for pressurizing product within the compression chamber and dispensing an amount of product within the compression chamber. 1. A dispenser for dispensing a substance , comprising:a body including a variable-volume storage chamber for storing the substance therein;a dispensing portion connected with the body and defining a compression chamber connectable in fluid communication with the storage chamber for receiving substance therefrom, and an outlet aperture coupled in fluid communication with the compression chamber;a one-way valve including a valve seat and a flexible valve cover overlying the valve seat and defining a normally-closed, seam therebetween forming a fluid-tight seal between the valve cover and the valve seat, wherein the flexible valve cover is movable relative to the valve seat and the seam is connectable in fluid communication with the outlet aperture to allow passage of an amount of the substance through the seam and out of the ...

Fluid Dispenser Having a One-Way Valve, Pump, Variable-Volume Storage Chamber, and a Needle Penetrable and Laser Resealable Portion

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. 1. A dispenser for dispensing a fluid , comprising:a rigid housing;a flexible bladder mounted within the housing and defining an interior chamber within the flexible bladder, and a fluid-receiving chamber between the flexible bladder and the rigid housing; andfirst means for creating a first pressure within the fluid-receiving chamber greater than a second pressure within the interior chamber of the bladder and thereby preventing the ingress of gases or vapors into the fluid-receiving chamber.2. A dispenser as defined in claim 1 , further comprising:a pump coupled in fluid communication with the fluid-receiving chamber for pumping a fluid received therein from the dispenser; anda one-way valve coupled in fluid communication with the pump for allowing the passage of the pumped fluid therethrough and preventing the passage of fluids in the opposite direction.3. A dispenser as defined in claim 1 , wherein the flexible bladder is movable between a collapsed condition upon filling the fluid-receiving chamber with a fluid and an expanded condition upon dispensing the fluid from the fluid-receiving chamber.4. A dispenser as defined in claim 3 , wherein the first means is formed by a resilient ...

Multi-Dose Vial and Method

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 variable-volume storage chamber within the body for storing multiple doses of the substance therein, 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 variable-volume 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. 1. A device for storing multiple doses of a substance to be dispensed into one or more syringes or other delivery devices , comprising:a body;a storage chamber within the body for storing multiple doses of the substance therein; anda one-way valve connectable in fluid communication with a syringe or other delivery device and moveable between first and second positions, and having a closed position preventing substance from passing therethrough and an open position permitting substance to pass therethrough;wherein, in the first position the one-way valve is prevented from opening into the open position and substance from the storage chamber cannot pass therethrough, and in the second position the one-way valve is permitted to open into the open position so that the one-way valve permits substance from the storage chamber to flow therethrough and into the syringe or other delivery device connected in fluid communication therewith.2. A device as defined in claim 1 , wherein the one-way valve is configured to substantially prevent any fluid flow in a substantially opposite direction claim 1 , from the syringe or other delivery device claim 1 , therethrough claim 1 , and into the storage chamber.3. A device as defined in claim 1 , wherein the storage chamber comprises a variable-volume ...

Multiple Dose Syringe and Method

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. 1. A multiple dose syringe comprising:a first valve defining a first valve opening pressure;a storage chamber for storing multiple doses of a substance therein, and a storage chamber outlet for dispensing multiple doses of the stored substance therethrough;a second valve in fluid communication with the storage chamber outlet and defining a second valve opening pressure;a compression surface movable between first and second positions; anda compression chamber, the compression surface and the first valve being located at opposing ends of the compression chamber and defining the compression chamber therebetween;wherein (i) movement of the compression surface in a direction from the first position toward the second position creates a pressure differential across the first valve exceeding the first valve opening pressure and dispenses the dose of substance in the compression chamber through the first valve and out of the syringe, and (ii) movement of the compression surface in a direction from the second position toward the first position creates a pressure differential across the ...

Device with Co-Molded Closure, One-Way Valve, Variable-Volume Storage Chamber and Anti-Spritz Feature and Related Method

A device has a first part with a valve seat and storage chamber, and a second part with a flexible valve cover and actuator. The storage chamber may be formed from a pre-form blow-molded into a flexible pouch defining a variable-volume storage chamber. The flexible valve cover and valve seat form a normally closed valve seam therebetween. The valve cover is movable in response to fluid at an inlet to the seam exceeding a valve opening pressure of the one-way valve between (i) a normally closed position with valve cover and valve seat in contact with each other and defining the normally closed seam, and (ii) a second position with at least a portion of the valve cover spaced away from the valve seat to allow the fluid to pass through the seam. The one-way valve may have anti-spritz features for using the device to dispense a substance, such as to the eye. The device may contain prostaglandins without the device material absorbing the prostaglandins material and/or without the material being adsorbed into the drug. 1. A device comprising:a first piece including a storage chamber adapted for storing a substance therein, an outlet in fluid communication with the storage chamber, and an elongated generally annular valve seat;a second piece defining a closure configured to seal an interior of the storage chamber with respect to ambient atmosphere with the second piece engaged with the first piece, and including an elongated generally annular flexible valve member configured to sealingly engage the valve seat with the second piece engaged with the first piece to define a one way valve defining an elongated, generally annular, normally closed valve seam between the valve seat and the valve member, an inlet at one end of the seam, an outlet spaced relative to the inlet at another end of the seam, and a valve opening pressure;wherein the valve member is moveable in response to substance at the inlet exceeding the valve opening pressure between (i) a first position with the ...

SELF CLOSING CONNECTOR

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. 1. A connector comprising:a first connector portion including a piercing member comprising a hollow shaft, a tip formed at one end of the shaft, at least one port in fluid communication with an interior of the hollow shaft, and a closure; wherein at least one of the closure and the shaft is movable between (i) a first position wherein the closure closes the at least one port, and (ii) a second position opening the at least one port;a second connector portion adapted to engage the first connector portion and including a pierceable septum configured to be pierced by the piercing member when the first connector portion and the second connector portion are in an engaged position with each other;wherein at least one of the first connector portion and the second connector portion is moveable relative to each other between (i) a closed position wherein the at least one of the closure and the shaft is in the first position and closes the at least one port and (ii) an open position wherein the at least one port has at least partially penetrated through the septum and the at least one of the closure ...

MODULAR FILLING APPARATUS AND METHOD

An apparatus and method for sterile filling comprises de-contaminating a needle penetrable surface of a device including a needle penetrable septum and a sealed chamber in fluid communication with the needle penetrable septum. A filling needle penetrates the needle penetrable septum, introduces substance through the filling needle and into the chamber and is, in turn, withdrawn from the septum. A liquid sealant is applied to the penetrated region of the septum. Radiation or energy is applied to the liquid sealant to cure the liquid sealant from a liquid phase to a solid phase. 1. A method comprising the following steps:(i) de-contaminating at least a penetrable surface of a device including a needle penetrable portion or septum penetrable by a filling or injection member and a sealed chamber in fluid communication with the penetrable septum;(ii) moving at least one of a filling or injection member and the device relative to the other to penetrate the penetrable septum with the filling or injection member, introducing substance through the filling or injection member and into the chamber, and withdrawing the filling or injection member from the septum;(iii) applying a liquid sealant onto the penetrated region of the septum; and(iv) applying radiation or energy to the liquid sealant to cure the liquid sealant from a liquid phase to a solid phase and hermetically seal the penetrated region of the septum.2. A method as defined in claim 1 , wherein step (iv) further includes applying radiation or energy to the liquid sealant and curing the liquid sealant from a liquid phase to a solid phase substantially at either about ambient temperature or about room temperature.3. A method as defined in claim 1 , further comprising introducing an overpressure of sterile air or other gas over the device during each of steps (ii) through (iii).4. A method as defined in claim 3 , further comprising applying a higher pressure of sterile air or other gas during step (ii) as compared to ...

DEVICE FOR CONNECTING OR FILLING AND METHOD

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. 1. A connector comprising:a first connector portion including a filling member comprising a hollow shaft, a tip formed at one end of the shaft, at least one port in fluid communication with an interior of the hollow shaft, and a closure; wherein at least one of the closure and the shaft is movable between (i) a first position wherein the closure closes the at least one port, and (ii) a second position opening the at least one port;a second connector portion adapted to engage the first connector portion and including a valve, having a flexible valve member and a valve seat, configured to be moved between (i) a closed position, wherein the flexible valve member is sealingly engaged by the valve seat, thereby preventing the flow of fluid therethrough, and (ii) an open position, wherein the flexible valve member is disengaged from the valve seat to allow the flow of fluid therethrough;wherein at least one of the first connector portion and the second connector portion is moveable relative to each other between (i) a disconnected position wherein the at least one of the closure and the shaft is in the first position and the valve is in the closed position and (ii) a connected position wherein the filling member has engaged and moved the valve from ...

TRANSFER PORT AND METHOD FOR TRANSFERRING ITEMS

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. 1. A method for sterile transfer of items sealed within a container , the method comprising the following steps:providing a transfer port having a door for sealing a transfer opening of the transfer port;providing a container having a mounting member thereon, an adhesive on an external surface of the container overlying the mounting member, and a releasable backing over said adhesive;removing the releasable backing;mounting a portion of the container to the transfer port with the adhesive so as to create a seal about the door;heating a heating element mounted about a peripheral portion of the door to a temperature sufficient to cut the container;moving the heating element on the door between retracted and extended positions to cut a portion of the container;heating a peripheral region of the transfer opening to prevent migration of contaminants therethrough;opening the door after cutting the container and heating the peripheral region of the transfer opening; andtransferring at least one article from the container through the transfer opening.2. A method as defined in claim 1 , wherein the step of providing a container includes the steps of:placing the at least one article in an inner container; andsealing the inner container within the container.3. A method as defined in claim 2 , further comprising the step of sterilizing ...

STERILE FILLING MACHINE HAVING FILLING STATION AND E-BEAM CHAMBER

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. 1. A method as defined in claim 21 , further comprising the following steps:prior to the penetrating step, sterilizing the at least one sealed, empty device by subjecting said at least one device to radiation capable of penetrating through the penetrable portion and into the chamber; andconveying the at least one device to a sterilizing station and sterilizing at least an external surface of the penetrable portion.2. A method as defined in claim 21 , wherein the at least one device comprises a plurality of devices claim 21 , and further comprising moving the conveyor by a motor and holding the devices in predetermined positions thereon.3. A method as defined in claim 21 , wherein the introducing step comprises introducing one of a sterile medicament claim 21 , cosmetic and food product into the chamber of the at least one device.4. (canceled)5. A method as defined in claim 1 , further comprising transporting the at least one device on the conveyor from the sterilizing station to a filling station including therein the at least one injection member.6. A method as defined in claim 1 , wherein the step of sterilizing ...

Device with penetrable septum, filling needle and penetrable closure, and related method

A device has a sealed chamber; a first penetrable septum in fluid communication with the chamber that is formed of an elastic material and is penetrable by a first injection member to fill the first chamber with a substance therethrough; and a second penetrable septum movable between first and second positions. In the first position, at least a portion of the second septum is spaced away from the first septum to allow the injection member to penetrate the first septum and aseptically or sterile fill the chamber with a substance therethrough. In the second position, the portion of the second septum overlies and seals a resulting injection aperture in the first septum after withdrawal of the first injection member therefrom, and is penetrable by a second injection member to penetrate the first and second septums and withdraw a filled substance from the chamber and through the second injection member.

APPARATUS AND METHOD FOR FILLING AND RESEALING

Apparatus for filling containers having stoppers that are penetrable for filling the containers with a substance, and thermally resealable for thermally sealing the resulting hole. A container support supports at least one such container in a substantially fixed position during filling and resealing. A manifold drivingly mounted over the container support comprises (1) a cartridge including a filling needle for penetrating the resealable stopper and introducing a substance therethrough into the container, 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 includes a thermal source for heating a penetrated region of the stopper and, sealing the hole. 1. An apparatus 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 , the apparatus comprising:a container support for supporting at least one container having a resealable stopper in a substantially fixed position during at least one of needle filling and thermally resealing a needle hole in the stopper upon withdrawal of a needle therefrom; anda manifold drivingly mounted over the container support and comprising (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 at least one of transportation, installation and removal of the needle cartridge from the manifold, and removable from the needle cartridge upon mounting the needle cartridge to the manifold; and (2) a thermal source for ...

Dispensing Machine Valve and Method

A one-way valve is connectable in fluid communication with a fluid-receiving chamber, such as a dilution chamber or a mixing chamber for diluting or mixing a perishable food product, such as a milk product or chocolate product, and forming a substantially fluid-tight seal therebetween. The valve comprises a relatively rigid valve seat, and a relatively flexible valve member overlying the valve seat and forming an axially-elongated, normally-closed valve opening therebetween defining an inlet at one end of the valve seat, an outlet at an opposite end of the valve seat, and an axially-extending seal therebetween that forms a fluid-tight seal between the inlet and outlet of the normally-closed valve opening. An axially-extending valve body is radially spaced relative to the valve member and forms a space therebetween allowing fluid-flow therethrough for cleaning the valve and the fluid-receiving chamber. A seal is engageable with the fluid-receiving chamber and forms a substantially fluid-tight seal therebetween to seal the valve outlet and fluid-receiving chamber with respect to ambient atmosphere. The valve member is movable radially away from the valve seat in response to substance at the inlet to the valve opening exceeding a valve opening pressure to flow into the normally closed valve opening, through the outlet, and into the fluid-receiving chamber. 1. A valve connectable in fluid communication with a fluid-receiving chamber and forming a substantially fluid-tight seal therebetween , the valve comprising a relatively rigid valve seat , a relatively flexible valve member overlying the valve seat and forming an axially-elongated , normally-closed valve opening therebetween defining an inlet at one end of the valve seat , an outlet at an opposite end of the valve seat , and an axially-extending seal therebetween that forms a fluid-tight seal between the inlet and outlet of the normally-closed valve opening , an axially-extending valve body radially spaced relative ...

Ready to Drink Container with Nipple and Penetrable and Resealable Portion, and Related Method

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. 1. An apparatus comprising:a container including a body defining a chamber for receiving a product;a container closure including a sealing portion forming a substantially fluid-tight seal between the container closure and the body, and a nipple, wherein the container closure seals the chamber with respect to the ambient atmosphere during storage of the product in the chamber and can be opened to dispense product from the chamber through the nipple; anda penetrable and resealable portion that is penetrable by an injection member for aseptically filling the chamber with the product through the injection member, and a resulting penetration hole is resealable to seal the product within the chamber.2. An apparatus as defined in claim 1 , wherein the nipple includes a sealing member that is movable between a first position sealing the nipple claim 1 , and a second position opening the nipple and allowing product in the chamber to be dispensed therethrough.3. An apparatus as defined in claim 2 , wherein the sealing member is frangibly connected to the nipple such that in the first position the sealing member is connected to ...

DISPENSER WITH VARIABLE-VOLUME STORAGE CHAMBER, ONE-WAY VALVE, AND MANUALLY-DEPRESSIBLE ACTUATOR

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. A compression chamber is coupled in fluid communication between the piston and one-way valve, and at least one of the piston and valve is manually depressible relative to the other between (i) a first position in which the piston is located at least partially outside of the compression chamber for permitting substance to flow from the variable-volume storage chamber into the compression chamber, and (ii) a second position in which the piston is located at least partially within the compression chamber for pressurizing substance within the compression chamber above a valve opening pressure and, in turn, dispensing substance through the one-way valve and out of the dispenser. 1. A dispenser comprising:a housing;a variable-volume storage chamber located 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 manually engageable surface mounted on the dispenser that is manually engageable and depressible to actuate the dispenser, wherein the manually engageable surface is manually depressible between first and second positions and is normally biased in a direction from the second position toward the first position;a one-way valve mounted on the dispenser and connectible in fluid communication with the variable-volume storage chamber, wherein the one-way valve includes an elastic valve member defining a normally closed outlet forming a substantially fluid-tight seal that prevents a flow of the substance therethrough but that allows the substance within the valve to flow therethrough when ...

Device With Co-Extruded Body and Flexible Inner Bladder and Related Apparatus and Method

A device comprises a first portion including a first polymer, and a second portion that is relatively flexible in comparison to the first portion and includes a second polymer that is substantially not bondable to the first polymer. A chamber of the device is hermetically sealable with respect to ambient atmosphere and is defined by (i) an interior of the second portion, and/or (ii) a space formed between the first and second portions. A third portion of the device includes a third polymer that is bondable to the first and second polymers and fixedly secures the first and second portions to each other. 155-. (canceled)56. A closure for a device comprising:a base including a valve seat and configured to sealingly engage an open end of a device and form a fluid tight seal therebetween and thereby close the device; anda support configured to sealingly engage the base and form a fluid tight seal therebetween, movable between a first position where the support does not sealingly engage the base and a second position where the support sealingly engages the base, and including a flexible or elastic valve member configured to engage the valve seat when the support is engaged with the base in the second position and form a one-way valve defining a normally closed valve opening between the valve seat and the flexible valve member.57. A closure as defined in claim 56 , further comprising a hinge operably connecting the base and the support and configured to allow the base and the support to move relative to the other between the first position and the second position.58. A closure as defined in claim 57 , wherein the hinge comprises a flexible hinge or living hinge.59. A closure as defined in claim 56 , wherein the valve seat and flexible valve member define an interference fit therebetween.60. A closure as defined in claim 56 , wherein the one-way valve substantially prevents the ingress of bacteria and other contaminants through the valve opening in both the normally closed ...

SELF CLOSING AND OPENING FILLING NEEDLE, NEEDLE HOLDER, FILLER AND METHOD

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. 1. A method comprising:penetrating a penetrable septum with a penetrating tip of an assembly including a hollow member including at least one port adjacent to the penetrating tip in fluid communication between an interior and an exterior of the hollow member, and a closure;during a first phase of penetration of the septum, locking one or more of the member or the closure in a closed position with the closure closing the at least one port and forming a fluid-tight seal between the at least one port and ambient atmosphere to maintain sterility of the at least one port and the interior of the member; andduring a second phase of penetration of the septum, unlocking and allowing relative movement of one or more of the closure and the member relative to the other, and opening the at least one port; andflowing substance through the open at least one port of the hollow member.2. A method as defined in claim 1 , further comprising terminating the flow of substance through the at least one port claim 1 , withdrawing the hollow member from the septum claim 1 , and allowing the ...

DEVICE WITH CO-EXTRUDED BODY AND FLEXIBLE INNER BLADDER AND RELATED APPARATUS AND METHOD

A device comprises a first portion including a first polymer, and a second portion that is relatively flexible in comparison to the first portion and includes a second polymer that is substantially not bondable to the first polymer. A chamber of the device is hermetically sealable with respect to ambient atmosphere and is defined by (i) an interior of the second portion, and/or (ii) a space formed between the first and second portions. A third portion of the device includes a third polymer that is bondable to the first and second polymers and fixedly secures the first and second portions to each other. 1a first portion including a first polymer;a second portion that is relatively flexible in comparison to the first portion including a second polymer that is substantially not bondable to the first polymer, and a chamber that is hermetically sealable with respect to ambient atmosphere and defined by at least one of (i) an interior of the second portion, and (ii) a space formed between the first and second portions; anda third portion including a third polymer that is bondable to the first and second polymers and that fixedly secures the first and second portions to each other.. A device comprising: This patent application is a continuation claiming the benefit under 35 U.S.C. § 120 of similarly-titled U.S. patent application Ser. No. 15/608,864, filed May 30, 2017, which is a continuation of U.S. patent application Ser. No. 14/930,896, filed Nov. 3, 2015, now U.S. Pat. No. 9,663,274 issued May 30, 2017, which is a continuation of U.S. patent application Ser. No. 13/847,277, filed Mar. 19, 2013, now U.S. Pat. No. 9,211,983 issued Dec. 15, 2015, which is a continuation of U.S. patent application Ser. No. 12/577,126, filed Oct. 9, 2009, now U.S. Pat. No. 8,397,950 issued Mar. 19, 2013, which claims the benefit under 35 U.S.C. § 119(e) of U.S. Provisional Patent Application No. 61/104,613, filed Oct. 10, 2008, entitled “Device with Co-Extruded Body and Flexible Inner ...

Pouch connector and related method

A pouch connector includes a safety cap having a cap base portion and a main connector disposed opposite the safety cap. The main connector and safety cap are configured to receive a portion of a pouch therebetween. The main connector includes a piercing member for piercing the pouch, an actuating portion for actuating the piercing member and a main connector base portion. The piercing member is configured to pierce through a portion of the pouch so as to provide fluid communication between a substance inside the pouch and the interior of the main connector. A polymeric membrane is coupled to at least one of the cap base portion and the main connector base portion.

DEVICE WITH CO-EXTRUDED BODY AND FLEXIBLE INNER BLADDER AND RELATED APPARATUS AND METHOD

A device comprises a first portion including a first polymer, and a second portion that is relatively flexible in comparison to the first portion and includes a second polymer that is substantially not bondable to the first polymer. A chamber of the device is hermetically sealable with respect to ambient atmosphere and is defined by (i) an interior of the second portion, and/or (ii) a space formed between the first and second portions. A third portion of the device includes a third polymer that is bondable to the first and second polymers and fixedly secures the first and second portions to each other. 1. A device comprising:a first portion including a first polymer;a second portion that is relatively flexible in comparison to the first portion including a second polymer that is substantially not bondable to the first polymer, and a chamber that is hermetically sealable with respect to ambient atmosphere and defined by at least one of (i) an interior of the second portion, and (ii) a space formed between the first and second portions; anda third portion including a third polymer that is bondable to the first and second polymers and that fixedly secures the first and second portions to each other.2. (canceled)3. (canceled)4. A device as defined in claim 1 , wherein the first polymer includes first and second monomers claim 1 , the second polymer includes second and third monomers that are different than the first and second monomers and substantially not bondable thereto claim 1 , and the third polymer includes fourth and fifth monomers claim 1 , wherein the fourth monomer is at least substantially similar and bondable to at least one of the first and second monomers for bonding the third polymer to the first polymer claim 1 , and the fifth monomer is at least substantially similar and bondable to at least one of the third and fourth monomers for bonding the third polymer to the second polymer.5. A device as defined in claim 4 , wherein the fourth monomer is the same ...

Self closing connector

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.

Multiple Dose Vial and Method

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.

Method for Molding and Assembling Containers With Stoppers and Filling Same

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. 1. A method comprising the following steps:(a) molding a container body in a first mold cavity;(b) molding a resealable member in a second mold cavity; (i) moving the resealable member into engagement with the container body which is located at least partially within the first mold cavity, assembling the resealable member to the container body, and forming a substantially sterile, sealed container body and resealable member assembly;', '(ii) moving the container body into engagement with the resealable member which is located at least partially within the second mold cavity, assembling the container body to the resealable member, and forming a substantially sterile, sealed container body and resealable member assembly; and', '(iii) assembling at least one of the container body and resealable member to the other with each of the container body and resealable member at a bactericidal temperature, and forming a substantially sterile, sealed container body and resealable member assembly;, '(c) assembling at least one of the container body and resealable member to the other at container body and resealable member temperatures greater than an ambient temperature, said assembling further including at least one of(d) transferring the container body and resealable member assembly to a filling and resealing ...

DEVICES AND METHODS FOR FORMULATION PROCESSING

Apparatuses and methods for controlling transfer of substances to a formulation container to provide a predetermined formulation. A controller may utilize one or more of a flow time, flow rate or a volume of transfer of substance. Barcoded and RFID-containing components may be used to determine what connection or disconnection has been made, and/or time thereof. Process compliance may compare measured or determined flow or connection time, flow rate and/or the transfer volume to a predetermined time, flow rate and/or volume, and adjust one or more of the time, flow rate and/or the volume of the transfer. An optional holder or cradle is configured to receive therein a fluid transfer connector formed by the connection of first and second connector portions, each in fluid communication with a flow conduit or channel that delivers substance to or receives substance from its respective connector portion, only if the connector portions are properly connected together. One or more sensors may be used to determine identification information of the connector and/or flow rates of substance through the connector. 1. An apparatus for controlling transfer of a substance to maintain a predetermined formulation , the apparatus comprising:a cradle having a body defining a first interior cavity portion therein configured to receive therein a substance transfer connector formed by the connection of a first connector portion and a second connector portion, wherein the cradle is configured and dimensioned to receive the connector therein only when the first connector and the second connector are properly connected together.2. An apparatus as defined in claim 1 , wherein the first interior cavity portion includes at least a portion of a reader or sensor configured to read or determine identification information of the connector claim 1 , and the apparatus is further configured to transmit said identification information to a controller configured to control substance transfer flow ...

DEVICE WITH CLOSURE INCLUDING BASE WITH VALVE SEAT AND SUPPORT WITH VALVE MEMBER, PENETRABLE PORTION AND ACTUATOR

A device comprises a first portion including a first polymer, and a second portion that is relatively flexible in comparison to the first portion and includes a second polymer that is substantially not bondable to the first polymer. A chamber of the device is hermetically sealable with respect to ambient atmosphere and is defined by (i) an interior of the second portion, and/or (ii) a space formed between the first and second portions. A third portion of the device includes a third polymer that is bondable to the first and second polymers and fixedly secures the first and second portions to each other. 155-. (canceled)56. A device comprising:a storage chamber; and (i) a base defining an aperture in fluid communication with the storage chamber and including an axially-elongated valve seat; and', an axially-elongated, elastic valve member;', 'a penetrable and resealable portion;', 'a compressive surface; and', 'a manually-engageable actuator coupled to the compressive surface;, '(ii) a support including, 'wherein the support is engageable with the base to secure the support to the base and form a fluid-tight seal therebetween, and in such position, the elastic valve member is engaged with the valve seat and forms a one-way valve defining a normally-closed, axially-extending valve opening between the elastic valve member and the valve seat, the penetrable and resealable portion is in fluid communication with the storage chamber and is penetrable by an injection member for filling the storage chamber with a fluid, a compression chamber is located between the support and the compressive surface and is connectable in fluid communication with the storage chamber to receive fluid from the storage chamber, the compressive surface is received within the compression chamber, and the manually-engageable actuator is coupled to one or more of the compression chamber and compressive surface, and one or more of the compressive surface and the compression chamber is movable relative ...

MULTIPLE DOSE SYRINGE AND METHOD

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. 1. A method comprising the following steps:i. storing multiple doses of a substance to be dispensed in a variable-volume storage chamber of a syringe;ii. releasing a dose of substance from the variable-volume storage chamber into a compression chamber of the syringe;iii. compressing the dose of substance in the compression chamber above a first valve opening pressure of an outlet valve of the syringe;iv. releasing the dose of substance through an outlet valve of the syringe;v. maintaining the substance in the storage chamber and compression chamber one or more of sterile or aseptic throughout steps i through iv; andvi. repeating steps ii through v with the same syringe.2. A method as defined in claim 1 , wherein the compressing step includes manually actuating an actuator to compress the dose of substance in the compression chamber above the outlet valve opening pressure.3. A method as defined in claim 2 , further comprising moving a compression surface away from the outlet valve and claim 2 , in turn claim 2 , creating at least a partial vacuum in the compression chamber and ...

Sterilizing Apparatus and Related Method

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. 118-. (canceled)19. A method comprising:(i) placing an object into a housing(ii) transmitting a fluid sterilant into the housing;(iii) moving or flowing the fluid sterilant in a desired flow pattern within the housing;(iv) contacting the fluid sterilant with at least a portion or surface of the object for a sufficient time to sterilize at least said portion or surface, and thereby sterilizing at least said portion or surface with the fluid sterilant; and(v) removing the fluid sterilant from the housing.20. A method as defined in claim 19 , wherein the removing step includes drawing the fluid sterilant out of the housing with at least one vacuum source.21. A method as defined in claim 19 , wherein the removing step further comprises exhausting or pumping the fluid sterilant through an exhaust manifold of the housing.22. A method as defined in claim 21 , further comprising chemically processing the fluid sterilant during or after the removing step.23. A method as defined in claim 19 , further comprising transmitting a sterile gas into ...

Dispenser with Variable-Volume Storage Chamber, One-Way Valve, and Manually-Depressible Actuator

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. A compression chamber is coupled in fluid communication between the piston and one-way valve, and at least one of the piston and valve is manually depressible relative to the other between (i) a first position in which the piston is located at least partially outside of the compression chamber for permitting substance to flow from the variable-volume storage chamber into the compression chamber, and (ii) a second position in which the piston is located at least partially within the compression chamber for pressurizing substance within the compression chamber above a valve opening pressure and, in turn, dispensing substance through the one-way valve and out of the dispenser. 1. A dispenser comprising:a housing;a variable-volume storage chamber located 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 manually engageable surface mounted on the dispenser that is manually engageable and depressible to actuate the dispenser, wherein the manually engageable surface is manually depressible between first and second positions and is nominally biased in a direction from the second position toward the first position;a one-way valve mounted on the dispenser and connectible in fluid communication with the variable-volume storage chamber, wherein the one-way valve includes an elastic valve member defining a normally closed outlet forming a substantially fluid-tight seal that prevents a flow of the substance therethrough but that allows the substance within the valve to flow therethrough when ...

Device for connecting or filling and method

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.

DISPENSING MACHINE VALVE AND METHOD

A one-way valve is connectable in fluid communication with a fluid-receiving chamber, such as a dilution chamber or a mixing chamber for diluting or mixing a perishable food product, such as a milk product or chocolate product, and forming a substantially fluid-tight seal therebetween. The valve comprises a relatively rigid valve seat, and a relatively flexible valve member overlying the valve seat and forming an axially-elongated, normally-closed valve opening therebetween defining an inlet at one end of the valve seat, an outlet at an opposite end of the valve seat, and an axially-extending seal therebetween that forms a fluid-tight seal between the inlet and outlet of the normally-closed valve opening. An axially-extending valve body is radially spaced relative to the valve member and forms a space therebetween allowing fluid-flow therethrough for cleaning the valve and the fluid-receiving chamber. A seal is engageable with the fluid-receiving chamber and forms a substantially fluid-tight seal therebetween to seal the valve outlet and fluid-receiving chamber with respect to ambient atmosphere. The valve member is movable radially away from the valve seat in response to substance at the inlet to the valve opening exceeding a valve opening pressure to flow into the normally closed valve opening, through the outlet, and into the fluid-receiving chamber. 1. A valve connectable in fluid communication with a fluid-receiving chamber and forming a substantially fluid-tight seal therebetween , the valve comprising a relatively rigid valve seat , a relatively flexible valve member overlying the valve seat and forming an axially-elongated , normally-closed valve opening therebetween defining an inlet at one end of the valve seat , an outlet at an opposite end of the valve seat , and an axially-extending seal therebetween that forms a fluid-tight seal between the inlet and outlet of the normally-closed valve opening , an axially-extending valve body radially spaced relative ...

READY TO FEED CONTAINER WITH DRINKING DISPENSER AND SEALING MEMBER, AND RELATED METHOD

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. 1. A container for storing and dispensing a product , the container comprising:a body defining a chamber for storing the product and an outflow port in fluid communication with the chamber; and a primary seal,', 'a secondary seal forming a substantially fluid-tight seal between the container closure and the body, and', 'a dispensing member defining an outlet aperture in fluid communication with the outflow port,', 'wherein at least one of the container closure and body is movable relative to the other between a first position where the primary seal is seated about the outflow port to hermetically seal the product in the chamber, 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 the outlet aperture of the dispensing member to dispense the product., 'a container closure including2. A container as defined in claim 1 , further including at least one additional chamber claim 1 , the at least one additional chamber located in at least one of (i) the body of the container claim 1 , (ii) the container closure ...

ONE-WAY VALVE AND APPARATUS AND METHOD OF USING THE VALVE

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. 1. A flexible pouch and valve assembly 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 , wherein the flexible pouch and valve assembly are receivable within a relatively rigid housing and 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 comprising: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; anda one-way valve including a valve body defining an axially-extending valve seat and at least one flow aperture extending through at least one of the valve body and valve seat; and a valve cover mounted on the valve body, and including an axially-extending portion formed of an elastic material, overlying the valve seat and covering a substantial axially-extending ...

DISPENSER AND APPARATUS AND METHOD FOR FILLING A DISPENSER

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. 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 an evacuating/dispensing member to evacuate the storage chamber, and by introducing fluid from the filling member through the open filling valve and into the storage chamber. The filling member is withdrawn from the valve, and a spring moves the valve to a closed position to hermetically seal the fluid within the dispenser.

Modular Filling Apparatus and Method

An apparatus and method for sterile filling comprises de-contaminating a needle penetrable surface of a device including a needle penetrable septum and a sealed chamber in fluid communication with the needle penetrable septum. A filling needle penetrates the needle penetrable septum, introduces substance through the filling needle and into the chamber and is, in turn, withdrawn from the septum. A liquid sealant is applied to the penetrated region of the septum. Radiation or energy is applied to the liquid sealant to cure the liquid sealant from a liquid phase to a solid phase. 1. A method comprising the following steps:(i) de-contaminating at least a penetrable surface of a device including a needle penetrable portion or septum penetrable by a filling or injection member and a sealed chamber in fluid communication with the penetrable septum;(ii) moving at least one of a filling or injection member and the device relative to the other to penetrate the penetrable septum with the filling or injection member, introducing substance through the filling or injection member and into the chamber, and withdrawing the filling or injection member from the septum;(iii) applying a liquid sealant onto the penetrated region of the septum; and(iv) applying radiation or energy to the liquid sealant to cure the liquid sealant from a liquid phase to a solid phase and hermetically seal the penetrated region of the septum.2. A method as defined in claim 1 , wherein step (iv) further includes applying radiation or energy to the liquid sealant and curing the liquid sealant from a liquid phase to a solid phase substantially at either about ambient temperature or about room temperature.3. A method as defined in claim 1 , further comprising introducing an overpressure of sterile air or other gas over the device during each of steps (ii) through (iii).4. A method as defined in claim 3 , further comprising applying a higher pressure of sterile air or other gas during step (ii) as compared to ...

ONE-WAY VALVE AND APPARATUS AND METHOD OF USING THE VALVE

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.

DEVICE WITH SLIDING STOPPER AND RELATED METHOD

A device that has a device body defining an opening at one end thereof, a storage chamber within the device body for storing multiple doses of a substance therein, and a sliding stopper, sealing engageable with the device body, through which the chamber is filled. The stopper has a body and a flexible portion, which may be in the form of a plurality of flexible members, extending therefrom. The flexible portion or members are movable between first and second positions. In the first position, during filling, the portion or members are substantially laterally extending from the stopper body and engaging the opening of the device body. Accordingly, the axial position of the stopper with respect to the device body is secured during filling of the chamber therethrough. In the second position, after filling, the portion or members are substantially axially-extending from the stopper body and disengaged from the rim or opening of the device body. Accordingly, the stopper is axially slideable through the body. 1. A device for storing a substance to be dispensed , comprising:a device body defining an opening at one end thereof;a storage chamber within the device body for storing a substance therein; anda sliding stopper, sealingly engageable within the device body, having a stopper body adapted for filling the substance into the storage chamber therethrough and a flexible portion or a plurality of flexible members extending from the stopper body, wherein the flexible portion or members are movable between (i) a first position, wherein the flexible portion or members are substantially laterally extending from the stopper body and engaging the opening of the device body, thereby securing the axial position of the stopper with respect to the device body during filling of the chamber therethrough, and (ii) a second position, wherein the flexible portion or members are substantially axially-extending from the stopper body and substantially disengaged from the opening of the ...

DEVICE WITH CO-MOLDED CLOSURE, ONE-WAY VALVE AND VARIABLE-VOLUME STORAGE CHAMBER, AND RELATED METHOD

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. The flexible valve cover and valve seat form a normally closed axially and angularly extending valve seam therebetween. 143-. (canceled).44. A closure for a device , comprising:a base including a valve seat, and configured to sealingly engage an open end of a device to form a fluid tight seal therebetween and thereby close the device; anda support configured to sealingly engage the base to form a fluid tight seal therebetween, wherein the support is movable between a first position in which the support does not sealingly engage the base, and a second position in which the support sealingly engages the base;wherein the support includes a flexible or elastic valve member configured to engage the valve seat when the support is engaged with the base in the second position, and form a one-way valve defining a normally closed valve opening and a hermetic seal between the valve seat and the valve member;wherein the valve member is movable between the normally closed position and an open position with at least a portion of the valve member ...

CONTROLLED NON-CLASSIFIED FILLING DEVICE AND METHOD

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. 1. An apparatus comprising:a formulation container including a formulation chamber that is sealed with respect to ambient atmosphere;at least one inlet port in fluid communication with the formulation chamber;at least one outlet port in fluid communication with the formulation chamber;a plurality of substance supply containers, each containing substance therein;a plurality of sterile or aseptic connectors sealingly connected in fluid communication with the at least one inlet port, wherein each of the plurality of connectors is normally closed and defines a flow conduit therein that is sterile and sealed with respect to ambient atmosphere for preventing exposure of any substance flowing therein to the ambient atmosphere and is configured to place the at least one inlet port in fluid communication with a respective substance from a respective supply container, wherein the plurality of connectors seal the at least one inlet port with respect to ambient atmosphere;and at least one outlet sterile or aseptic connector sealingly connected in fluid communication with the at least ...

POUCH WITH SEALED FITMENT AND METHOD

A pouch comprises a film including (i) a fold defining a fold plane and a first marginal edge portion of the pouch, (ii) a first side transverse to the fold plane, and (iii) a second side opposite the first side and transverse to the fold plane. A fitment of the pouch includes a port and a base. The base defines a mid-portion engaging the fold at the fold plane, a first side located on one side of the mid-portion, and a second side located on an opposite side of the mid-portion relative to the first side. The first and second sides of the base are transverse to the fold plane, and are engaged with the first or second sides of the film, respectively. The base or film overlaps the other and defines an overlapping region. The base and film are sealed to each other within the overlapping region and form a fluid-tight seal that extends about the port. 1. A pouch comprising:a film including a fold defining a fold plane and a first marginal edge portion of the pouch, a first side transverse to the fold plane, and a second side opposite the first side and transverse to the fold plane; anda fitment including a port and a base defining a mid-portion engaging the fold at the fold plane, a first side located on one side of the mid-portion, and a second side located on an opposite side of the mid-portion relative to the first side, wherein (i) at least one of the first and second sides of the base is transverse to the fold plane and engaged with the first or second side of the film, respectively, (ii) at least one of the base or film overlaps the other and defines an overlapping region, and (iii) at least one of the base or film is sealed to the other within the overlapping region and defines a fluid-tight seal between the base and film that extends about the port.2. A pouch as defined in claim 1 , wherein the first side of the base is located on one side of and is transverse to the fold plane claim 1 , and is engaged with the first side of the film claim 1 , and the second side ...

Single-use needle assembly and method

A needle assembly that has a flexible shield movable between (i) a first position, where the flexible shield is uncompressed, and (ii) a second position, where the flexible shield is compressed and an administering member located within the flexible shield, where at least one of the administering member and the flexible shield is axially movable with respect to the other of the administering member and the flexible shield in an unlocked position prior to and during usage of the needle assembly, and the at least one of the administering member and the flexible shield is no longer axially movable with respect to the other of the administering member and the flexible shield in a locked position. Prior, during and after use of the needle assembly, the needle is never exposed. After a single usage of the needle assembly, the needle is locked within the flexible shield and cannot be reused.

Aseptic Connector with Deflectable Ring of Concern and Method

An aseptic fluid connector having a first connector including a first fluid passageway for receiving a fluid therein; a first port in fluid communication with the first fluid passageway for passage of the fluid therethrough; and a first deflecting member. The first deflecting member includes a first engaging portion radially spaced relative to the first port, and a first valve movable between a closed position and an open position with movement of the first engaging portion between a non-deflected position and a deflected position, respectively. In the non-deflected position, the first valve is located in the closed position forming a fluid-tight seal between the first valve and first port and preventing the passage of fluid therethrough, and in the deflected position, the first valve is located in the open position allowing the aseptic passage of fluid through the first port. 135-. (canceled)36. An aseptic fluid connector comprising:a first connector including:a first fluid passageway for receiving a fluid therein;a first port in fluid communication with the first fluid passageway for passage of the fluid therethrough; anda first member, configurable between a first configuration preventing the passage of fluid through the first port and hermetically sealing all fluid-contacting surfaces of the first connector with respect to the ambient atmosphere for preventing external contamination of said surfaces, and a second configuration defining a first aseptic passageway to allow the aseptic passage of fluid through the first port and through the first aseptic passageway; anda second connector connectable to the first connector and including:a second fluid passageway for receiving a fluid therein;a second port in fluid communication with the second fluid passageway for passage of the fluid therethrough; anda second member, configurable between a first configuration preventing the passage of fluid through the second port and hermetically sealing all fluid-contacting ...

DEVICE WITH PENETRABLE AND RESEALABLE PORTION AND RELATED METHOD

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. 1. A thermoplastic portion that is pierceable with an injection or filling member to form an aperture therethrough , and is resealable to hermetically seal the aperture , wherein the thermoplastic portion includes (i) a first polymeric material in a first amount by weight including a styrene block copolymer and defining a first elongation; (ii) a second polymeric material in a second amount by weight that is less then the first amount , including at least one of an ethylene alpha-olefin , a polyolefin , and an olefin , and defining a second elongation that is less than the first elongation.2. A thermoplastic portion as defined in claim 1 , wherein the thermoplastic portion is thermally resealable.3. A thermoplastic portion as defined in claim 2 , wherein the thermoplastic portion is heat resealable by applying laser radiation at least one of a predetermined wavelength and a predetermined power thereto.4. A thermoplastic portion as defined in claim 3 , wherein the predetermined wavelength is approximately 980 nm.5. A thermoplastic portion as defined in claim 1 , further comprising ...

LATERALLY-ACTUATED DISPENSER WITH ONE-WAY VALVE FOR STORING AND DISPENSING SUBSTANCES

A dispenser has a body with a variable-volume storage chamber for storing product. A compression chamber is in fluid communication with the storage chamber for receiving substance therefrom. A one-way valve of the dispenser includes valve seat and flexible valve cover seated on the valve seat and defining a normally-closed seam therebetween forming a 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 through the seam and out of the dispenser. A manually-engageable actuator connected to the dispensing portion is movable between first and second positions to dispense substance within the compression chamber out of the dispenser. 1. A device for storing substance to be dispensed , comprising:a body defining a variable-volume storage chamber for storing substance; anda stopper slidingly receivable within the body and sealingly engageable therewith to form a fluid-tight seal therebetween, having a penetrable portion that is penetrable by a needle or like filling member for filling the variable-volume storage chamber with a substance therethrough, and configured to be engaged by a filling apparatus for securing the position of the stopper with respect to the body during filling of the variable-volume storage chamber.2. A device as defined in claim 1 , wherein the stopper further comprises at least one sealing member configured to sealingly engage an inner wall of the body in at least one location to form said fluid-tight seal therebetween.3. A device as defined in claim 2 , wherein the at least one sealing member includes two axially spaced sealing members.4. A device as defined in claim 2 , wherein the at least one sealing member engages the inner wall in at least two axially-spaced locations.5. A device as defined in claim 2 , wherein the at least one sealing member is annular.6. A device as defined in claim 1 , wherein the stopper comprises a relatively resilient ...

Sealed Containers and Methods of Filling and Resealing Same

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. 1. A method comprising:forming a body defining a chamber in a first mold in a clean room environment;forming, in a second mold in the same clean room environment as the first mold, a penetrable and resealable portion that is pierceable with a filling or injection member to form a penetration aperture therethrough and is resealable to hermetically seal the penetration aperture by applying radiation or energy to the penetrable and resealable portion; andassembling the penetrable and resealable portion and body in the clean room environment to form an assembly defining a sealed empty chamber.2. A method as defined in claim 1 , wherein the first and second molds are located side-by-side within the clean room environment.3. A method as defined in claim 1 , wherein the penetrable and resealable portion is defined by one of (i) a body closure and (ii) a stopper.4. A method as defined in claim 1 , further comprising filling the chamber with a substance while the penetrable and resealable portion and body are assembled.5. A method as ...

DELIVERY DEVICE WITH SEPARATE CHAMBERS CONNECTABLE IN FLUID COMMUNICATION WHEN READY FOR USE, AND RELATED METHOD

A device and method are provided for storing substances separately, and for mixing the substances prior to use. The device defines at least one first chamber for receiving a first substance, and at least one second chamber for receiving a second substance. A first sealing portion is located between the first and second chambers and is movable between a closed position preventing fluid communication between the chambers, and an open position permitting fluid communication between the first and second chambers for mixing the substances. First and second penetrable and resealable portions in fluid communication with the first and second chamber(s), respectively, may be used for filling by penetrating them with an injection member and introduce the substances therethrough and into the respective chamber, and resealing the injection apertures and the substances within the respective chamber. 1. A method comprising: a body defining at least one first chamber that is empty and sealed from the ambient atmosphere for receiving therein a first substance, and at least one second chamber that is empty and sealed from the ambient atmosphere for receiving therein a second substance;', 'at least one first sealing portion extending between the at least one first and second chambers in a closed position preventing fluid communication between the at least one first and second chambers, and transformable from the closed position to an open position permitting fluid communication between the at least one first and second chambers for mixing the first and second substances when ready for use;', 'a first penetrable and resealable portion in fluid communication with only the at least one first chamber and defining a hermetic seal between the at least one first chamber and the ambient atmosphere, wherein the first penetrable and resealable portion is penetrable by an injection member to form an injection aperture therethrough to aseptically introduce the first substance through the ...

CONTROLLED NON-CLASSIFIED FILLING DEVICE AND METHOD

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. 1. A method , comprising the following steps:(a) penetrating an elastic septum of a device with an injection member, wherein the device defines a sealed, empty, sterile chamber in fluid communication with the elastic septum;(b) during the penetrating step, forming an annular interface between the elastic septum and the injection member extending axially between a penetration point on an interior surface of the elastic septum in fluid communication with the sterile chamber, and an exterior surface of the septum engaging the injection member, and de-contaminating the injection member by at least one of (i) friction between the elastic septum and injection member at the annular interface, and (ii) elongation of the elastic septum at the annular interface;(c) introducing a substance through the injection member and into the sterile chamber of the device;(d) withdrawing the injection member from the elastic septum;(e) allowing the elastic septum to reseal itself at a penetration aperture resulting from withdrawal of the injection member; and(f) maintaining the chamber sterile ...

DEVICE WITH CO-MOLDED CLOSURE, ONE-WAY VALVE AND VARIABLE-VOLUME STORAGE CHAMBER, AND RELATED METHOD

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. The flexible valve cover and valve seat form a normally closed axially and angularly extending valve seam therebetween. 1. A one way valve comprising:a semi-annular, 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; anda flexible valve member superimposed on the valve seat and defining 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 on the first mid-portion of the valve seat and forming a normally closed axially and angularly extending valve seam therebetween, wherein the valve seam defines an inlet at approximately one end thereof and an outlet axially spaced relative to the inlet at approximately another end thereof, the valve cover and valve seat define a first degree ...

CONTROLLED NON-CLASSIFIED FILLING DEVICE AND METHOD

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. 1. An apparatus comprising:a formulation container including a formulation chamber that is sealed with respect to ambient atmosphere;at least one inlet port in fluid communication with the formulation chamber;at least one outlet port in fluid communication with the formulation chamber;a plurality of substance supply containers, each containing substance therein;a plurality of sterile or aseptic connectors sealingly connected in fluid communication with the at least one inlet port, wherein each of the plurality of connectors is normally closed and defines a flow conduit therein that is sterile and sealed with respect to ambient atmosphere for preventing exposure of any substance flowing therein to the ambient atmosphere and is configured to place the at least one inlet port in fluid communication with a respective substance from a respective supply container, wherein the plurality of connectors seal the at least one inlet port with respect to ambient atmosphere;and at least one outlet sterile or aseptic connector sealingly connected in fluid communication with the at least ...

MULTIPLE DOSE DEVICE AND METHOD

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. 1. A method comprising:i. storing multiple doses of a substance to be dispensed in a variable-volume storage chamber of a device that is hermetically sealed from ambient atmosphere;ii. aseptically transferring a dose of substance from the variable-volume storage chamber into a compression chamber of the device that is hermetically sealed from ambient atmosphere;iii. compressing the dose of substance in the compression chamber above a first valve opening pressure of an outlet valve of the device;iv. releasing the dose of substance through the outlet valve of the device;v. transferring the dose of substance into an administering member releasably attached to the device for administering a dispensed dose of substance to a patient, without said dose passing through or contacting any structure between the outlet valve and administering member;vi. throughout steps i through iv, maintaining the substance in the storage chamber and compression chamber one or more of sterile or aseptic and preventing said dose from exposure to ambient atmosphere; andvii. repeating steps ii, iii, iv, and ...

ADJUSTABLE FILLING AND SEALING METHOD AND APPARATUS THEREFOR

An assembly includes a support and drive assembly, a first structure and a second structure. The first structure is in operable communication with and supported by the support and drive assembly. The first structure includes at least one filling or needle assembly and is adjustable to receive a plurality of filling or needle assemblies. The second structure is supported by the support and drive assembly. The second structure includes at least one seal assembly and is adjustable to receive a plurality of seal assemblies. A method includes determining a number of containers or vials that are to be filled concurrently and adjusting an assembly to include at least one filling or needle assembly and at least one seal assembly. A number of the filling or needle assemblies and the seal assemblies equals the number of containers or vials. 1. A method comprising:determining a number of containers that are to be filled concurrently; andadjusting an adjustable assembly, which is adjustable to receive one or more filling assemblies and one or more seal assemblies, to include at least one of said filling assemblies and at least one of said seal assemblies; such that a number of said filling assemblies and said seal assemblies equals said number of containers.2. The method of claim 1 , further comprising feeding said number of containers into said adjustable assembly in a side by side relationship.3. A method as defined in claim 1 , wherein said filling assemblies include a number of filling members equal to said number of containers.4. A method as defined in claim 1 , wherein said containers comprise vials.533.-. (canceled)34. A method as defined in claim 3 , wherein said filling member comprises a needle.35. A method as defined in claim 1 , further comprising the steps of filling the containers with said filling assembles and sealing the containers after filling the containers with said seal assemblies.36. A method as defined in claim 1 , wherein said seal assemblies are ...

TRANSFER PORT AND METHOD FOR TRANSFERRING ITEMS

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. 1. A method for sterile transfer of items sealed within a container , the method comprising the following steps:providing a transfer port having a door for sealing a transfer opening of the transfer port;providing a container having a mounting member thereon, an adhesive on an external surface of the container overlying the mounting member, and a releasable backing over said adhesive;removing the releasable backing;mounting a portion of the container to the transfer port with the adhesive so as to create a seal about the door;heating a heating element mounted about a peripheral portion of the door to a temperature sufficient to cut the container;moving the heating element on the door between retracted and extended positions to cut a portion of the container;heating a peripheral region of the transfer opening to prevent migration of contaminants therethrough;opening the door after cutting the container and heating the peripheral region of the transfer opening; andtransferring at least one article from the container through the transfer opening.2. A method as defined in claim 1 , wherein the step of providing a container includes the steps of:placing the at least one article in an inner container; andsealing the inner container within the container.3. A method as defined in claim 2 , further comprising the step of sterilizing ...

APPARATUS AND METHOD FOR TRACING PRIMARY AND PROCESS DEVICES, AND CLOSED STERILE TRANSFER FORMULATION AND FILLING IN CONNECTION WITH THE TRACED DEVICES

An apparatus and method for electronically tracing primary devices and process devices, and closed transfer formulation and/or filling the traced primary devices. Each of the primary devices and process devices includes an electronic identifier, such as an RFID tag or barcode. Scanners read the electronic identifiers, and transmit the read identification information to a controller. The controller compares the read identification information to required identification information for a respective product specification, and transmits a signal to further proceed with a formulation or filling process, or not, based on the comparison. 1. A method comprising:(i) reading identification information defined by electronic identifiers on one or more primary devices or process devices;(ii) transmitting the read identification information to a controller, comparing the read identification information to required identification information for a respective specification, and transmitting a signal to further proceed or not based on the comparison; and(iii) if a signal to further proceed is transmitted, transferring by closed sterile transfer one or more substances from said one or more primary devices to said one or more process devices or from said one or more process devices to said one or more primary devices.2. A method as defined in claim 1 , wherein the identification information includes first information identifying the respective device and distinguishing the device from other devices.3. A method as defined in claim 2 , wherein the identification information further includes second information on the condition or processing status of the respective device.4. A method as defined in claim 3 , wherein the second information includes whether the respective device was subjected to sterilization in a sealed claim 3 , empty state.5. A method as defined in any one of to claim 3 , wherein the closed sterile transfer is without exposure of the transferred substance to the ambient ...

METHOD FOR DISPENSING OPHTHALMIC FLUID

An ophthalmic dispenser and method of filling and dispensing fluid stored therein. The dispenser includes a rigid housing defining a fluid-receiving chamber, a flexible bladder receivable within the fluid-receiving chamber, a pump coupled in fluid communication with the fluid-receiving chamber, and a nozzle having a valve defining an annular, axially-extending valve seat, an outlet aperture coupled in fluid communication between the valve seat and the pump, and a flexible valve cover extending about the valve seat and forming an annular, axially-extending interface therebetween. The valve interface is connectable in fluid communication with the outlet aperture, and at least part of the valve cover is movable between (i) a normally closed position with the valve cover engaging the valve seat to close the interface and form a fluid-tight seal therebetween, and (ii) an open position with at least part of the valve cover spaced away from the valve seat in response to pumped fluid flowing through the outlet aperture at a pressure greater than a valve opening pressure to allow the passage of pressurized fluid therebetween. The rigid housing is mountable within a cartridge which, in turn, is mountable within a dispenser housing including an eyelid depressor and a trigger for simultaneously actuating the eyelid depressor and pump. 1. A method comprising:providing a plurality of cartridges for storing and dispensing an ophthalmic fluid, the plurality of cartridges being substantially identical to one another and each having a vial, a pump, and a nozzle, the vial including an interior fluid receiving chamber defined therein, the pump being in fluid communication with the fluid receiving chamber for pumping a fluid received therein from the cartridge, the nozzle being disposed in fluid communication with the pump for allowing the passage of the pumped fluid therethrough, the cartridge further having a casing that retains the nozzle, the pump, and the vial arranged in that ...

DEVICE AND RELATED METHOD

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. 17-. (canceled)8. A dispenser for dispensing a substance , comprising:a body including a variable-volume storage chamber for storing the substance;a dispensing portion connected with the body and defining a dosage chamber coupled in fluid communication with the storage chamber for receiving substance therefrom, and an outlet aperture coupled in fluid communication with the dosage chamber;a first valve forming an external portion of the dispenser and including a valve seat and a flexible valve cover seated on the valve seat defining an interference fit therewith and defining a normally-closed seam therebetween forming a fluid-tight seal between the valve cover and valve seat, wherein the flexible valve cover is movable relative to the valve seat and the seam is connectable in fluid communication with the outlet aperture to allow the passage of substance through the seam and out of the dispenser;a second valve coupled in fluid communication between the dosage chamber and the storage chamber that allows the flow of substance ...

SELF CLOSING AND OPENING FILLING NEEDLE, NEEDLE HOLDER, FILLER AND METHOD

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. 1. An apparatus for filling a device including a penetrable septum and a sealed chamber in fluid communication with the penetrable septum , comprising:a hollow filling member, a penetrating tip formed at one end of the filling member that is engageable with the penetrable septum to penetrate the septum, at least one port in fluid communication between an interior of the hollow filling member and an exterior of the hollow filling member, and a closure, wherein(A) at least one of the closure and filling member is movable between (i) a first position wherein the closure closes the at least one port and forms a fluid-tight seal between the at least one port and ambient atmosphere to maintain sterility of the at least one port and an interior of the filling member, and (ii) a second position opening the at least one port to allow substance to pass between said interior and said exterior; and(B) at least one of the filling member and septum is movable relative to the other between (i) a first position wherein the penetrating tip is spaced from the septum, and (ii) a second ...

SEALED CONTAINERS AND METHODS OF FILLING AND RESEALING SAME

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 resealable member may be dome-shaped or have a convex outer surface. A 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, and resealing the penetration hole in the resealable member made by the injection member during penetration. 119-. (canceled)20. A method , comprising:(a) penetrating an elastic septum a device with an injection member, wherein the device defines a sealed, empty sterile chamber in fluid communication with the elastic septum, and the elastic septum defines a dome shape or a convex outer surface;(b) introducing a substance through the injection member and into the sterile chamber of the device;(c) withdrawing the injection member from the elastic septum;(d) allowing the elastic septum to reseal itself at a penetration aperture resulting from withdrawal of the injection member; and(e) maintaining the chamber sterile throughout steps (a) through (d).21. A method as defined in claim 20 , wherein the elastic septum defines a substantially convex exterior surface claim 20 , and a substantially concave interior surface opposite the convex exterior surface.22. A method as defined in claim 21 , wherein the elastic septum includes a penetration zone defining an approximate dome shape claim 21 , and the penetrating step includes penetrating the elastic septum in the dome-shaped penetration zone.23. A method as defined in claim 22 , wherein the approximately dome-shaped penetration zone defines a substantially convex exterior surface and a substantially concave interior surface.24. A method as defined in claim 20 , wherein the elastic septum is ...

DISPENSER WITH ONE-WAY VALVE FOR STORING AND DISPENSING SUBSTANCES

A dispenser has a body with a storage chamber for storing product. A one-way valve of the dispenser includes a valve seat and flexible valve cover seated on the valve seat and defining a normally-closed seam therebetween forming a 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 through the seam and out of the dispenser. 113-. (canceled)14. A device comprising:an integral first piece including a storage chamber adapted for storing a substance therein, an outlet in fluid communication with the storage chamber, and a valve seat;an integral second piece defining a closure configured to hermetically seal an interior of the storage chamber with the second piece engaged with the first piece, and including a flexible valve member configured to sealingly engage the valve seat with the second piece engaged with the first piece to define a one way valve defining a normally closed valve seam between the valve seat and the valve member, an inlet at one end of the seam, an outlet spaced relative to the inlet at another end of the seam to define an outlet of the device, and a valve opening pressure;wherein the valve member is moveable in response to substance at the inlet exceeding the valve opening pressure between (i) a first position with the valve member and valve seat forming the normally closed seam and (ii) a second position with at least a portion of the valve member spaced away from the valve seat to allow the substance to pass through the valve seam from the inlet and to dispense the substance through the outlet at the another end of the valve seam and out of the device.15. A device as defined in claim 14 , wherein the outlet of the normally closed valve seam is spaced axially relative to the inlet of the normally closed valve seam.16. A device as defined in claim 14 , wherein the valve seat is elongated and generally annular claim 14 , the valve member is elongated ...

SEPTUM THAT DECONTAMINATES BY INTERACTION WITH PENETRATING ELEMENT

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. 1. A septum comprising:an exterior surface located on an external side of the septum, and an interior surface located on an opposite side of the septum;a penetration portion penetrable by a needle or other penetrating element extending between the exterior and interior surfaces; the septum applies a zone of relatively high, approximately radial pressure onto the needle or other penetrating element at or near the exterior surface and applies a zone of relatively lower, approximately radial pressure onto the needle or other penetrating element at or nearer to the interior surface; and', 'the septum progressively wipes an exterior surface of the needle or other penetrating element at at least the zone of relatively high, approximately radial pressure and thereby decontaminates portions of the needle or other penetrating element that has penetrated the septum., 'wherein, when the penetration portion is penetrated with the needle or other penetrating element'}2. A septum as defined in claim 1 , ...

One-way valve and apparatus and method of using the valve

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.

DISPENSER AND APPARATUS AND METHOD FOR FILLING A DISPENSER

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. 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 an evacuating/dispensing member to evacuate the storage chamber, and by introducing fluid from the filling member through the open filling valve and into the storage chamber. The filling member is withdrawn from the valve, and a spring moves the valve to a closed position to hermetically seal the fluid within the dispenser. 1. A dispenser comprising:a body;a variable volume storage chamber formed within the body;a filling valve coupled in fluid communication with the storage chamber and defining (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 to at least one of withdraw fluid therethrough to evacuate the storage chamber, and to introduce fluid therethrough to fill the storage chamber;a ...

DEVICE FOR CONNECTING OR FILLING AND METHOD

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. 192-. (canceled)93. An apparatus , comprising:a first portion including a conduit comprising a hollow interior, at least one port in fluid communication with the interior, and a closure; wherein one or more of the closure or the conduit is movable between (i) a first position wherein the closure closes the at least one port, and (ii) a second position opening the at least one port;a second portion adapted to engage the first portion and including (1) a valve, having a valve member and a valve seat, configured to be moved between (i) a closed position, wherein the valve member and the valve seat sealingly engage each other, thereby preventing the flow of substance through the valve, and (ii) an open position, wherein the valve member and the valve seat are disengaged from each other to allow the flow of substance through the valve, and (2) a septum overlying one or more of the valve member or the valve seat;wherein one or more of the first portion or the second portion is moveable relative to each other between (i) a disconnected position wherein the one or more of the closure or the conduit is in the first position and the valve is in the closed position and (ii) a connected position wherein the conduit has engaged and moved the valve from the ...

Ocular treatment apparatus

Ocular treatment apparatus

Eye treatment facility.

Fluid dispenser having a housing and flexible inner bladder

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.

Syringe and reconstitution syringe

Ophthalmic dispenser and associated method

An ophthalmic dispenser has a rigid housing defining a fluid-receiving chamber, a flexible bladder receivable within the fluid-receiving chamber, a pump coupled in fluid communication with the fluid-receiving chamber, and a nozzle having a valve defining an annular, axially-extending valve seat, an outlet aperture coupled in fluid communication between the valve seat and the pump, and a flexible valve cover extending about the valve seat and forming an annular, axially-extending interface therebetween. The valve interface is connectable in fluid communication with the outlet aperture, and at least part of the valve cover is movable between (i) a normally closed position with the valve cover engaging the valve seat to close the interface and form a fluid-tight seal therebetween, and (ii) an open position with at least part of the valve cover spaced away from the valve seat in response to pumped fluid flowing through the outlet aperture at a pressure greater than a valve opening pressure to allow the passage of pressurized fluid therebetween. A spring is drivingly connected to the housing and moves at least one of the pump and housing relative to the other to actuate the pump. The rigid housing is mountable within a cartridge which, in turn, is mountable within a dispenser housing including an eyelid depressor and a trigger for simultaneously actuating the eyelid depressor and pump.

Fluid dispenser having a rigid vial and flexible inner bladder

A dispenser (10) for dispensing a fluid includes a rigid vial (52) that has a main fluid chamber (55) containing a fluid, and a pump assembly (50) that is in fluid communication with the main fluid chamber (55) and is configured to dispense a predetermined quantity of fluid from the main fluid chamber (55). A flexible bladder (54) is provided which is located within the main fluid chamber (55) and is configured to expand to fill the ullage created within the main fluid chamber (55) during dispensing of fluid by the pump assembly (50). The resilient bladder (54) tends to force itself outwardly toward the rigid vial (52) and, in turn, increases the pressure within the main fluid chamber (55) in comparison to the interior of the bladder (54) to thereby prevent the ingress of air or vapors through the bladder (54) or otherwise into the main fluid chamber (55).

Dispenser and method for storing and dispensing sterile food product

A syringe is provided for the delivery of controlled, metered amounts of any of numerous different substances to humans or animals, such as medicaments, pharmaceuticals, cosmetics, and food products, or to deliver materials which may react upon exposure to air, such as glue. The syringes include a body and a plunger. Means are provided in the syringe body and the plunger to effect controlled movement of the plunger into the syringe to permit delivery of a pre-determined amount of the substance contained in the syringe. A one-way valve is provided at the dispensing tip of the syringe to hermetically seal the portion of the syringe containing the substance to be dispensed.

Dispenser and apparatus for fillling a dispenser

A dispenser for holding multiple doses of fluids or other substances, and for dispensing the substances, has a vial, a flexib e ~ adder received within the vial, and a variable volume storage chamber formed between the bladder and vial. A filling valve is coupled in fluid communication 5 with the storage chamber and ~eSnes (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 511 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 10 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

Piston-type dispenser with one-way valve for storing and dispensing metered amounts of substances

A dispenser for dispensing a substance, such as a liquid lipstick or other product, has a body defining a variable-volume storage chamber for storing the product. A dispensing portion is connected with the body and defines a bore coupled in fluid communication with the storage chamber for receiving product therefrom, and an outlet aperture coupled in fluid communication with the bore. A piston is received within the bore, and a one-way valve is mounted on the dispensing portion for dispensing metered amounts of product therethrough. The one-way valve has an axially-extending valve seat, and an axially-extending visco-elastic valve cover seated on the valve seat and defining a normally-closed, axially-extending seam therebetween forming a fluid-tight seal between the valve cover and valve seat. The flexible valve cover is movable relative to the valve seat, and the seam is connectable in fluid communication with the outlet aperture to allow the passage of product through the seam and out of the dispenser. An actuator is drivingly connected to the piston for moving the piston within the bore and dispensing a predetermined amount of product within the bore through the outlet aperture.

Dispenser having variable-volume storage chamber and depressible one-way valve assembly for dispensing creams and other substances

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. A compression chamber is coupled in fluid communication between the piston and one-way valve, and at least one of the piston and valve is manually depressible relative to the other between (i) a first position in which the piston is located at least partially outside of the compression chamber for permitting substance to flow from the variable-volume storage chamber into the compression chamber, and (ii) a second position in which the piston is located at least partially within the compression chamber for pressurizing substance within the compression chamber above a valve opening pressuring and, in turn, dispensing substance through the one-way valve and out of the dispenser.

One-way valve and apparatus and method of using the valve

A flexible pouch defining a variable volume storage chamber and one-way valve assembly for aseptically storing a substance, dispensing multiple portions of the stored substance therefrom in cooperation with a pump, and maintaining substance remaining in the pouch in an aseptic condition sealed with respect to ambient atmosphere. The one-way valve includes a valve seat and elastic valve cover portion overlying the valve seat forming an interference fit therewith defining a normally-closed seam therebetween. The valve portion is movable radially between (i) a normally closed position with the valve portion engaging the valve seat, and (ii) an open position with at least a segment of the valve portion spaced radially away from the valve seat to allow substance from the storage chamber through the valve opening. The one-way valve maintains substance remaining in the variable-volume storage chamber in an aseptic condition sealed with respect to the ambient atmosphere.

One-way valve, apparatus and method of using the valve.

Un aparato tiene un cuerpo de valvula que define un primero paso, un asiento de valvula y una abertura de flujo que se extiende a traves del cuerpo de valvula y se acopla en comunicacion de fluido con el primer paso. Una cubierta de valvula del aparato se forma de un material elastico e incluye una base de cubierta montada sobre el cuerpo de valvula y fijado contra el movimiento en relacion al cuerpo, y una porcion de valvula que cubre el asiento de valvula. La porcion de valvula define un grosor radial predeterminado y forma un ajuste por interferencia con el asiento de valvula. La porcion de valvula y el asiento de valvula definen un orificio de valvula que se extiende axialmente y que normalmente esta cerrada. La porcion de valvula puede moverse entre una posicion normalmente cerrada con la porcion de valvula que se acopla con el asiento de valvula, y una posicion abierta con cuando menos un segmento de la porcion de valvula separada del asiento de valvula para conectar el orifico de valvula en comunicacion de fluido con la abertura de flujo para permitir asi el paso de fluido desde la abertura de flujo a traves del orificio de valvula.

Method for dispensing fluids

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. In the second position the fluid in the compression chamber exceeds a valve opening pressure and, in turn, moves the elastic valve member between (i) a normally closed position hermetically sealing the one-way valve and variable-volume storage chamber with respect to ambient atmosphere, and (ii) an open position permitting fluid flow through the valve opening.

Dispensing machine valve and method

Intradermal delivery device and method

Single use connectors

Connector assembly including a piercing member having a flow port therein attached to a first piece, with the piercing member slidingly receivable within a second piece, wherein the piercing member and the second pierce are movable relative to each other between a first position where the second pieces closes the flow port and a second position where the flow port is open. The first piece contains a locking mechanism that lockingly engages with a device when connected thereto, preventing subsequent disconnection of first piece and the device. Upon initial connection of the first piece to the device, the second piece is moved from the first position to the second position.

Connector for aseptic filling and transfer of fluids

A first portion includes a hollow shaft having a port and a closure relatively movable between a first position wherein the closure closes the port and a second port-exposed position. A second portion includes a valve member and a valve seat movable between a closed position, wherein the seat sealingly engages the member, and an open position allowing fluid flow. The first and/or second portions are relatively moveable between a disconnected position wherein the closure and/or the shaft is in the first position and the valve is in the closed position and a connected position wherein the valve is in the open position and the closure and/or the shaft is in the second position. In the first position, the closure hermetically seals the first portion thereby allowing aseptic passage of fluid through the first portion when the first and second portions are in the connected position.