Needle penetrable and laser 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:
- providing a device including a body defining a chamber enclosed by a liquid-impermeable closure in sealing engagement therewith and a penetrable and thermally resealable portion in fluid communication with the chamber;
penetrating the penetrable and thermally resealable portion with a tip of filling member such that a flow aperture of the filling member is in fluid communication with the chamber of the device;
introducing the substance to be lyophilized through the filling member and into the chamber of the device;
withdrawing the filling member from the penetrable and thermally 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 contaminants from flowing into the chamber during lyophilization; and
transmitting thermal energy from a thermal energy source onto a penetrated region of the penetrable and thermally resealable portion, and hermetically sealing an aperture formed by the filling member in the penetrated region of the penetrable and thermally resealable portion.
3 Assignments
0 Petitions
Accused Products
Abstract
A device and related method are provided for lyophilizing a substance within the device and storing therein the lyophilized substance. The device is penetrable by a needle for filling the device with the substance to be lyophilized, and a resulting needle hole in the device is laser resealable by transmitting thereon laser radiation from a laser source. The device defines a chamber for receiving therein the substance to be lyophilized. A needle penetrable and laser resealable portion of the device is pierceable with a needle to form a needle aperture therethrough to fill the chamber with the substance to be lyophilized through the needle, and is laser resealable to hermetically seal the needle aperture by applying laser radiation thereto. 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
14 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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providing a device including a body defining a chamber enclosed by a liquid-impermeable closure in sealing engagement therewith and a penetrable and thermally resealable portion in fluid communication with the chamber; penetrating the penetrable and thermally resealable portion with a tip of filling member such that a flow aperture of the filling member is in fluid communication with the chamber of the device; introducing the substance to be lyophilized through the filling member and into the chamber of the device; withdrawing the filling member from the penetrable and thermally 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 contaminants from flowing into the chamber during lyophilization; and transmitting thermal energy from a thermal energy source onto a penetrated region of the penetrable and thermally resealable portion, and hermetically sealing an aperture formed by the filling member in the penetrated region of the penetrable and thermally resealable portion. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14)
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Specification