Closed drug delivery system

A closed system for selectively mixing two separately stored components under sterile conditions, comprising:

• (a) a compressible chamber including a selectively gas-trapping compartment and a reservoir compartment in open communication with said gas-trapping compartment, said compressible chamber containing a sterile liquid component and a sterile gas;
• (b) a drug vial containing a drug component and sealed with a pierceable stopper;
• (c) means to access said compressible chamber adjacent to said gas-trapping compartment;
• (d) junction means permanently affixed about at least an end portion of said chamber access means and at least the exposed portion of said pierceable stopper, said junction means selectively maintaining said chamber access means end portion and said exposed portion of said pierceable stopper in sterile relation means;
• (e) said chamber access means including an element capable of selectively piercing said junction means and said pierceable stopper so as to establish a sterile pathway between said compressible chamber and said drug vial through said element and said pierceable stopper;
• (f) whereupon after said sterile pathway is established, said gas-trapping and reservoir compartments may be selectively positioned to facilitate proper mixing of the sterile liquid and the drug.

A method for selectively mixing two separately stored components in a closed system under sterile conditions, the system including a compressible chamber having a selectively gas-trapping compartment and a reservoir compartment in open communication with the gas-trapping compartment, the compressible chamber further having an internal wall having a closed end and an open end and segregating the gas-trapping and reservoir compartments except for an open flow path between the compartments adjacent the open end, the compressible chamber containing a liquid, first component, the system further including a container containing a second component, at least one of the compressible chamber and the container also containing a gas, the system also including means to access the compressible chamber adjacent the gas-trapping compartment, means to access the container, junction means permanently affixed about at least the end portions of each of the access means, the junction means selectively maintaining the end portions in sterile relation, at least one of the access means including an element capable of selectively piercing the junction means, the steps comprising:

• (a) urging the element through the junction means to connect the access means and establish a sterile pathway between the compressible chamber and the container;
• (b) transferring some of the liquid first component into the container through the pathway after some gas is in the container;
• (c) exchanging some of the liquid in the container with some of the liquid in the chamber by
• (i) manipulating the chamber until liquid in the gas-trapping compartment is adjacent the chamber access means and the chamber access means is above the gas-trapping compartment,
• (ii) compressing the chamber, thereby urging some liquid from the chamber into the container, and
• (iii) stopping said compression, thereby urging some liquid from the container into the chamber;
• and
• (d) emptying the liquid in the container into the chamber.