Abstract:
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.
Abstract:
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.
Abstract:
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.
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:
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.
Abstract:
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.
Abstract:
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.
Abstract:
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.
Abstract:
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.
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.