Penetrable and resealable lyophilization method
First Claim
1. A method of filling a device with a substance to be lyophilized, lyophilizing the substance within the device, and storing the lyophilized substance within the device, the method comprising the following steps:
- filling a device including a body defining a chamber enclosed by a liquid-impermeable closure in sealing engagement therewith and a penetrable and resealable portion in fluid communication with the chamber, the filling step comprising;
penetrating the penetrable and resealable portion with a tip of an injection or filling member such that a flow aperture of the injection or filling member is in fluid communication with the chamber of the device;
introducing the substance to be lyophilized through the injection or filling member and into the chamber of the device; and
withdrawing the injection or filling member from the penetrable and resealable portion;
lyophilizing the substance within the chamber with the closure in engagement with the body, causing fluid to flow out of the chamber during lyophilization, and preventing at least one of contaminants and moisture from flowing into the chamber during lyophilization; and
hermetically sealing an aperture formed by the injection or filling member in the penetrated region of the penetrable and resealable portion.
1 Assignment
0 Petitions
Accused Products
Abstract
Device and method for lyophilizing a substance within the device and storing therein the lyophilized substance. The device defines a chamber for receiving therein the substance to be lyophilized, a penetrable and resealable portion of the device is penetrable or pierceable by a needle for filling the device with the substance, and a resulting hole therein is resealable by transmitting radiation from a radiation source thereon. A filter is connectable in fluid communication between an interior and exterior of the chamber for permitting fluid to flow therethrough in a direction from the interior to the exterior of the chamber, and for substantially preventing contaminants from flowing therethrough in a direction from the exterior to the interior of the chamber.
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Citations
29 Claims
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1. A method of filling a device with a substance to be lyophilized, lyophilizing the substance within the device, and storing the lyophilized substance within the device, the method comprising the following steps:
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filling a device including a body defining a chamber enclosed by a liquid-impermeable closure in sealing engagement therewith and a penetrable and resealable portion in fluid communication with the chamber, the filling step comprising; penetrating the penetrable and resealable portion with a tip of an injection or filling member such that a flow aperture of the injection or filling member is in fluid communication with the chamber of the device; introducing the substance to be lyophilized through the injection or filling member and into the chamber of the device; and withdrawing the injection or filling member from the penetrable and resealable portion; lyophilizing the substance within the chamber with the closure in engagement with the body, causing fluid to flow out of the chamber during lyophilization, and preventing at least one of contaminants and moisture from flowing into the chamber during lyophilization; and hermetically sealing an aperture formed by the injection or filling member in the penetrated region of the penetrable and resealable portion. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 25, 26, 27, 28, 29)
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12. A method comprising the following steps:
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filling a sealed empty sterile device including a body defining a chamber, and a penetrable and resealable portion forming a liquid-tight seal between the chamber and ambient atmosphere, the filling step comprising penetrating the penetrable and resealable portion with an injection or filling member and sterile filling a liquid substance to be lyophilized into the sealed, empty, sterile chamber through the penetrable and resealable portion; providing at least one aperture through the penetrable and resealable portion to permit fluid to flow out of the chamber; lyophilizing the substance within the chamber; and closing the at least one aperture and hermetically sealing the lyophilized substance within the chamber. - View Dependent Claims (13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24)
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Specification