Abstract:
An aerosol tip mechanism for an aerosol-type dispenser for dispensing liquid content has a flexible outer shell, a rigid cap portion composed of lower and upper portions, and a rigid nozzle portion having a rigid shaft received within the outlet portion of the flexible outer shell. The rigid shaft interfaces the outlet portion of the outer shell, forming a first normally-closed one-way valve. The lower and upper portions of the rigid cap portion form boots adapted to receive an outlet portion of the flexible outer shell, the boots thereby constraining a lateral motion of the outlet portion of the outer shell, and symmetrically centering the outlet portion around the rigid shaft of the nozzle. The rigid nozzle portion includes a plurality of liquid channels for delivering liquid from a reservoir to a swirling chamber defined within the rigid cap portion, which liquid channels are configured to minimize energy losses of the liquid and promote a more homogeneous fluid particle size in the dispensed aerosol. The aerosol tip mechanism provides for long-term sterility of the stored fluid, which in turn allows for preservation of the sterility of non-chemically preserved formulations, which may be in the form of suspension or liquid gels.
Abstract:
A resealable cap (110, 210) for a medicament vial (114, 214) has a base portion (112, 212) formed of vulcanized rubber or like material known for providing a stable environment for the medicament contained within the vial, and a resealable portion (126, 226) overlying the base portion. The resealable portion (126, 226) is made of low-density polyethylene or like material, and can be punctured by a needle or like injection member (140, 282) for dispensing medicament into the vial (114, 214). Prior to filling, the cap (110, 210) is assembled to the vial (114, 214) and the cap/vial assembly is sterilized. Then, a needle (140, 282) is inserted through the cap (110, 210) and medicament is introduced through the needle and into the vial. Upon withdrawal of the needle (140, 282), the penetrated region of the cap (248) is fused by laser (276) or direct heat sealing (264) to hermetically seal the needle hole (294) in the cap.
Abstract:
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 flexible valve cover and valve seat form a normally closed valve seam there between. 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.
Abstract:
A needle has a hollow shaft, a tip formed at one end of the shaft, one or more ports in fluid communication with the interior of the hollow shaft, and a closure. The closure and/or the shaft is movable between (i) a first position wherein the closure closes the port(s), and (ii) a second position opening the port(s).
Abstract:
A 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.
Abstract:
A connector for transferring a fluid includes a first connector and a second connector. Each connector includes a first outer portion including a first obstructive portion and defining a first fluid passageway for receiving a fluid therein. Each connector further includes a first central nozzle coupled to the first outer portion. The central nozzle includes a first engagement member. The first central nozzle is movable between a first position and a second position with rotation of the first outer portion. In the first position, the first obstructive portion and the first engagement portion substantially overlap to impede fluid flow through the first fluid passageway. In the second position, at least one of the first engagement member and the first obstructive member is displaced to allow fluid flow through the first fluid passageway.
Abstract:
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.
Abstract:
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.
Abstract:
A flexible pouch and valve assembly is provided for aseptically storing a substance, dispensing multiple portions of the stored substance therefrom, and maintaining substance remaining in the pouch in an aseptic condition sealed with respect to ambient atmosphere. The flexible pouch and valve assembly are receivable within a relatively rigid housing, and are adapted to cooperate with a pump for pumping discrete portions of substance from the pouch and through the one-way valve to dispense the substance therefrom. The assembly comprises a Flexible pouch defining therein a variable-volume storage chamber sealed with respect to the ambient atmosphere for aseptically storing therein multiple portions of the substance. A one way valve of the assembly includes a valve body defining an axially-extending valve seat and at least one flow aperture extending through the valve body and/or the valve seat. A valve cover is mounted on the valve body, and includes an axially-extending portion formed of an elastic material overlying the valve seat and covering a substantial axially-extending portion thereof. The valve portion defines a predetermined radial thickness and forms an interference fit with the valve seat. The valve portion and the valve seat define an axially-extending seam therebetween forming a normally closed, axially-extending valve opening, and 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 connect the valve opening in fluid communication with the at least one flow aperture and thereby allow the passage of substance from the variable-volume storage chamber through the valve opening. In the normally closed and open positions, the one-way valve maintains substance remaining in the variable- volume storage chamber in an aseptic condition and sealed with respect to the ambient atmosphere.
Abstract:
An apparatus and method are provided for molding sterile parts. The apparatus has a first mold portion and a second mold portion. 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 At least one of the first and second mold portions 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 first and second mold portions and permitting the passage of a fluid sterilant therein. A fluid source that contains or otherwise generates a fluid sterilant, such as vaporized hydrogen peroxide, is connectable in fluid communication with the fluid passageway for introducing the sterilant into the fluid passageway with at least one of the first and second mold portions in the open position, and in turn 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.