Dual vial connecting system for lyophilized products

Fluent material handling – with receiver or receiver coacting mea – Plural materials – material supplies or charges in a receiver

Reexamination Certificate

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Details

C141S018000, C141S319000, C141S329000, C141S383000

Reexamination Certificate

active

06237649

ABSTRACT:

BACKGROUND OF THE INVENTION
The present invention concerns in a dual vial connecting system for temporary connection of two containers, usually a glass or plastic vial and a plastic solvent bottle, the purpose being to reconstitute a dry product, such as a lyophilisate, powder etc., contained in a glass or plastic vial with a corresponding solvent product contained in a plastic solvent bottle, the connecting system having a cylindrical closing and connecting plastic sleeve with a lower portion having inwardly directed securing means for secure connection with the neck of the glass or plastic vial, an upper portion having an internal thread for screwing connection with the plastic solvent bottle and an integrated plastic membrane being perforated by the orifice reducer of the plastic solvent bottle when screwed into the upper inner threaded portion of the closing and connecting plastic sleeve.
For reasons of stability, freshness, marketing aspects, etc., the two products are kept and stored in separate containers prior to their immediate use. During storage, the two containers are hermetically closed.
BRIEF SUMMARY OF THE INVENTION
The aim of the present invention is a dual connecting container system which does not require a rubber stopper but ensures a tight closure of the glass or plastic vial containing the lyophilisate etc., as well as a tight connection between the glass or plastic vial and the solvent bottle during the reconstitution phase.
According to the invention, this is achieved by the closing and connecting plastic sleeve having a perforable membrane separating the upper inner threaded portion from the lower portion of the closing and connecting plastic sleeve, an inner cylindrical skirt located in the inner lower portion of the closing and connecting plastic sleeve and extending downwardly from the lower surface of the perforable membrane said skirt having an outer diameter coming in contact with the wall of the inner neck of the glass or plastic vial, an elastomer sealing ring fixed at the uppermost position around the outer surface of the said skirt, an elastomer sealing plug with a pre-cut section and a cavity in its centre, the said sealing plug being placed around a cylindrical collar located in the inner upper portion of the closing and connecting plastic sleeve and extending upwardly from the upper surface of the perforable membrane, whereby the perforable membrane, the cylindrical skirt and the collar are integrally moulded parts of the said closing and connecting plastic sleeve.
According to a preferred embodiment of the invention the securing means comprises a threaded inner wall of the inner lower portion for engaging a corresponding thread on the outer surface of the glass or plastic vial neck. As a safeguard against removal of the closing and connecting plastic sleeve from the glass or plastic vial, the inner wall is provided with cogs engaging corresponding cogs on the outer surface of the glass or plastic vial neck. Moreover, the thread is interrupted by vertical grooves for keeping an open connection from the glass or plastic vial interior to the outside when the closing and connecting plastic sleeve is only partially screwed onto the said vial.
According to an alternative embodiment of the invention, the lower portion of the closing and connecting plastic sleeve has inwardly directed projections for snapping connection with an annular bulge around the outer surface of the neck of the glass or plastic vial.
According to another preferred embodiment, the elastomer sealing plug has a cavity in its center leaving a thinned area which functions as an elastomer membrane which is pre-cut in its center. When screwing the plastic solvent bottle into the upper inner threaded portion of the closing and connecting plastic sleeve, the orifice reducer of the said plastic solvent bottle first penetrates through the pre-cut area of the said sealing plug and then perforates the plastic membrane of the closing and correcting plastic sleeve.
Once the solvent bottle is completely screwed into the closing and connecting plastic sleeve, the wall of the orifice reducer come in contact with the wall of the cavity of the said sealing plug which assures a complete tightness between the two containers, the plastic solvent bottle is then squeezed in order to transfer the solvent product into the glass or plastic vial containing the lyophilisate, powder etc.,. When the reconstitution of the lyophilized product, forming the final product, is completed by shaking the assembly, the assembly is then inverted, having now the glass or plastic vial on top, the recalling of the reconstituted final product into the plastic solvent bottle can be achieved by squeezing and releasing the plastic solvent bottle again several times.
According to another embodiment of the present invention, the inner wall of the upper threaded portion of the closing and connecting plastic sleeve has an annular rib that operates as a snap and allowing to hold the sealing elastomer plug in place. The elastomer sealing ring assures a tightness when the closing and connecting plastic sleeve is completely screwed onto the threaded neck of the glass or plastic vial and comes in contact with the top surface of the neck of the said glass or plastic vial.


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