Lyophilization method and device
First Claim
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1. A method comprising the following steps:
- filling a sealed empty sterile device including a body defining a chamber, and a sealing portion forming a liquid-tight seal between the chamber and ambient atmosphere, wherein the filling step comprises sterile filling a liquid substance to be lyophilized through the sealing portion and into the sealed, empty, sterile chamber;
evacuating the chamber through a fluid passageway formed in the sealing portion;
lyophilizing the substance within the evacuated chamber; and
closing the fluid passageway through the sealing portion and hermetically sealing the lyophilized substance within the chamber.
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Abstract
A lyophilization device configured for use in a lyophilization process has a body defining a chamber for receiving a liquid to be lyophilized, and a stopper creating a liquid-tight seal between the chamber and ambient atmosphere to form a sealed, empty sterile chamber. The stopper is adapted so that the chamber may be sterile filled with the substance through the stopper. A fluid passageway is formed through the stopper, through which the chamber is evacuated. The substance is lyophilized, the fluid passageway is closed, and the lyophilized substance is hermetically sealed within the chamber.
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Citations
39 Claims
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1. A method comprising the following steps:
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filling a sealed empty sterile device including a body defining a chamber, and a sealing portion forming a liquid-tight seal between the chamber and ambient atmosphere, wherein the filling step comprises sterile filling a liquid substance to be lyophilized through the sealing portion and into the sealed, empty, sterile chamber; evacuating the chamber through a fluid passageway formed in the sealing portion; lyophilizing the substance within the evacuated chamber; and closing the fluid passageway through the sealing portion and hermetically sealing the lyophilized substance within the chamber. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 22, 23)
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- 14. A lyophilization device comprising a body defining a sealed, empty sterile chamber, and a sealing portion forming a liquid-tight seal between the chamber and ambient atmosphere, wherein the sealing portion is configured and adapted for sterile filling a liquid substance to be lyophilized through the sealing portion and into the sealed, empty, sterile chamber, forming a fluid passageway through the sealing portion and evacuating the chamber through the fluid passageway of the sealing portion, lyophilizing the substance within the evacuated chamber, and closing the fluid passageway through the sealing portion and hermetically sealing the lyophilized substance within the chamber.
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25. A system comprising:
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a valve assembly defining (i) an open position permitting passage of substance therethrough, and (ii) a closed position preventing passage of substance therethrough and forming a fluid-tight seal between an inlet end and an outlet end thereof, the valve assembly comprising a flexible valve member defining a spring that is approximately dome-shaped when the valve assembly is in the closed position; and a filling assembly including a filling member engageable with the valve assembly and coupleable in fluid communication with a substance source for introducing the substance through the valve assembly, wherein at least one of the valve assembly and the filling member is movable relative to the other to move the valve assembly between the closed and open positions and introduce the substance from the filling member through the valve assembly. - View Dependent Claims (26, 27, 28, 29, 30, 31, 32, 33, 34)
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35. A method comprising the following steps:
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engaging a valve assembly and a filling assembly with each other, the valve assembly defining (i) an open position permitting passage of substance therethrough, and (ii) a closed position preventing passage of substance therethrough and forming a fluid-tight seal between an inlet end and an outlet end thereof, and comprising a flexible valve member defining a spring that is approximately dome-shaped when the valve assembly is in the closed position; and
the filling assembly including a filling member engageable with the valve assembly and coupleable in fluid communication with a substance source for introducing the substance through the valve assembly,opening the valve assembly from the closed positions into the open position; and introducing substance from the filling member through the open valve assembly. - View Dependent Claims (36, 37, 38, 39)
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Specification