초록 ▼

Provided is a process for preparing an aseptic container for separately storing a sterilized powdered component and a sterilized liquid component under clean conditions. The container includes two sealed chambers having a frangible, sterilized connection therebetween, one said chamber containing the

Provided is a process for preparing an aseptic container for separately storing a sterilized powdered component and a sterilized liquid component under clean conditions. The container includes two sealed chambers having a frangible, sterilized connection therebetween, one said chamber containing the liquid component, and the other said chamber including a sealed vial containing a powdered component. The vial has an outer surface that is aseptic throughout its entire surface area, and the frangible connection provides a sterile pathway, when desired, between the interior of the vial and the interior of the liquid-containing chamber.

대표청구항 ▼

A process for producing an integral aseptic container for separately storing, mixing, and dispensing a sterilized powdered component and a sterilized liquid component in a manner that provides for mixing and dispensing of said powdered and liquid components under sterile conditions within said integ

A process for producing an integral aseptic container for separately storing, mixing, and dispensing a sterilized powdered component and a sterilized liquid component in a manner that provides for mixing and dispensing of said powdered and liquid components under sterile conditions within said integral container, comprising: providing a container having at least two separate and distinct compartments having a frangible connection therebetween, one such compartment having a dispensing outlet portion, another such compartment being for receiving a vial; sealing the vial-receiving compartment to form a closed chamber that is devoid of any carrier-liquid and of any powdered component; filling the compartment having the dispensing outlet portion with a carrier liquid; sealing the compartment having the dispensing outlet portion to seal the carrier liquid therewithin; sterilizing said container including said carrier liquid compartment, said closed chamber, including the interior thereof said frangible connection and said sealed dispensing portion while said closed chamber remains devoid of any carrier liquid and of any powdered component during said sterilizing step; opening, subsequent to said sterilizing step, an end of said closed chamber of the sterilized container while said container is within an aseptic environment; inserting a sealed vial into the chamber through the end that was opened during said opening step and while said container is within an aseptic environment, said vial containing a sterilized powdered component therewithin, said inserting step including positioning the sealed vial such that, when its seal is broken, the powdered component will enter into said frangible connection between the carrier liquid compartment and said chamber; and sealing, subsequent to said inserting step, said open end of said chamber while said container is within an aseptic environment, thereby sealing the vial within said chamber.