Apparatus and method for lyophilizing aseptic substances
First Claim
1. A device for suspending a resilient stopper relative to a container having an open end during lyophilization of a substance within the container, comprising:
- an upper portion positionable about the stopper in frictional engagement therewith; and
means for supporting the upper portion, said supporting means comprising a plurality of spaced legs depending from the upper portion and having downwardly facing shoulders engageable in abutting relationship with the open end of the container to space the upper portion and the stopper axially therefrom and provide a fluid path between the legs to the interior of the container;
whereby the stopper can be maintained in a first position spaced from the open end of the container to permit fluid communication with the interior of the container.
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Accused Products
Abstract
Apparatus for use in lyophilizing a substance in a container and sealing the substance within the container after lyophilization. The apparatus includes an upper portion positionable about a resilient stopper in frictional engagement therewith, and a structure supporting the upper portion. The supporting structure is positionable on the open end of the container to space the upper portion and the stopper axially therefrom and define at least one fluid path communicating with the interior of the container. The upper portion and the supporting means may define an axial passageway for conducting the stopper from the initial position to a sealing position at least partially within the open end of the container upon application of an axial force to the stopper.
48 Citations
13 Claims
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1. A device for suspending a resilient stopper relative to a container having an open end during lyophilization of a substance within the container, comprising:
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an upper portion positionable about the stopper in frictional engagement therewith; and means for supporting the upper portion, said supporting means comprising a plurality of spaced legs depending from the upper portion and having downwardly facing shoulders engageable in abutting relationship with the open end of the container to space the upper portion and the stopper axially therefrom and provide a fluid path between the legs to the interior of the container; whereby the stopper can be maintained in a first position spaced from the open end of the container to permit fluid communication with the interior of the container. - View Dependent Claims (2, 3, 4, 5, 6)
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7. Apparatus for use in lyophilizing a substance in a container having an open end and sealing the substance within the container after lyophilization, comprising:
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a resilient stopper; hollow means mountable coaxially to the open end of the container for suspending said resilient stopper in a first position spaced from the open end and permitting fluid communication with the interior of the container when the stopper is in said first position; means for lyophilizing a substance within the container when the stopper is in said first position; and means for driving the stopper through said hollow suspending means from said first position to a second sealing position, said second position being beyond said hollow suspending means and within the open end; such that communication with the interior of the container can be maintained during lyophilization and the container can thereafter be sealed. - View Dependent Claims (8, 9, 10, 11, 12)
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13. The method of lyophilizing a substance within a container having an open end sealable by an imperforate resilient stopper, which comprises:
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frictionally retaining the stopper within a support element mounted to the open end of the container such that the stopper is spaced from the open end and fluid communication with the interior of the container is maintained; lyophilizing the substance within the container while the stopper is retained within the support element; and driving the stopper from the support element into the open end to seal the container; whereby communication with the interior of the container is maintained during lyophilization for escape of the vapor produced, and the container is thereafter sealed.
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Specification