Process for preparing a lyophilized material
Inventors
Thilly, Jacques • Vandecasserie, Christian
Assignees
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Publication Number
US-8574213-B2
Publication Date
2013-11-05
Expiration Date
Abstract
A process for preparing a lyophilized material, providing a container having a penetrable envelope and containing the material in a carrier liquid, whereby the penetrable region is penetrated with a penetrator which provides a conduit through the envelope, and the carrier liquid is evaporated out of the container via the conduit, after which the penetrator is withdrawn.
Core Innovation
The described invention provides a process for lyophilizing a substance present in a carrier liquid by using a container closed by a closure made of elastomeric material having elasticity. The elastomeric material has a penetrable region with a previously-formed puncture hole that is closed at a rest stage of the closure. A penetrator having an engaging end is moved so that, during movement, the engaging end opens the previously-formed puncture hole to form an opening communication passage.
The process stops the movement of the penetrator at a second position so that the engaging end stops just before entering into the material of the closure. The penetrator is maintained in the second position by applying a compensating force to compensate for the elasticity of the elastomeric material. The carrier liquid is evaporated from the container via the opening communication passage by maintaining the substance in the carrier liquid at a temperature such that the carrier liquid is frozen and applying reduced pressure so that the frozen liquid sublimates directly from the solid to the vapor state.
After evaporating the carrier liquid, the compensating force applied on the penetrator is released and the penetrator is withdrawn from the elastomeric penetrable region. The previously formed puncture hole is provided in an elastomeric closure having an elastomeric elasticity that closes the puncture hole at a rest stage, and the disclosed further refinement includes sealing a residual puncture hole. The disclosed embodiments describe forming an opening communication passage by opening the previously-formed puncture hole during penetrator movement and then withdrawing the penetrator after sublimation under reduced pressure.
Claims Coverage
The partial content provides one independent claim (clm-00001). It includes multiple core inventive features centered on an elastomeric closure with a previously-formed puncture hole that is opened by a compensating-force-controlled penetrator to create an opening communication passage for sublimation-driven evaporation under reduced pressure.
Previously-formed puncture hole in elastomeric penetrable region opened by penetrator
Providing a container closed by a closure made of elastomeric material having elasticity, the elastomeric material having a penetrable region with a previously-formed puncture hole which is closed at a rest stage; providing a penetrator having an engaging end; and moving the penetrator so that the engaging end opens the previously-formed puncture hole to form an opening communication passage.
Compensating force maintained during opening-position sublimation evaporation
Stopping the movement of the penetrator at the second position so the engaging end stops just before entering into the material of the closure and maintaining the penetrator in the second position by applying a compensating force in order to compensate for the elasticity of the elastomeric material.
Reduced-pressure frozen-liquid sublimation via opening communication passage
Evaporating the carrier liquid of the substance from the container via the opening communication passage by maintaining the substance in the carrier liquid at a temperature such that the carrier liquid is frozen and applying reduced pressure so the frozen liquid sublimates directly from the solid to the vapor state; and releasing the compensating force and withdrawing the penetrator from the elastomeric penetrable region.
Sealing residual puncture hole after withdrawal
Using a vial with an elastomeric closure that includes a puncture hole in the elastomer vial closure and further sealing the residual puncture hole.
Across the independent claim and its refinements in the partial content, the central claim coverage is directed to opening a previously-formed puncture hole in an elastomeric penetrable region using a penetrator, maintaining penetrator position via a compensating force, evaporating by reduced-pressure sublimation of frozen carrier liquid through the resulting opening communication passage, and withdrawing the penetrator with sealing of any residual puncture hole.
Stated Advantages
Documented Applications
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