Separated packaging and sterile processing for liquid-powder mixing

Claim 1

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.