Container and Method of Manufacture of Container

摘要

A pre-loaded container and a method of manufacturing a pre-loaded vial is provided wherein one or more active agents is lyophilised within the vial cap and the vial cap is then sealed onto a vial retaining a suitable diluent to form the pre-loaded vial. Lyophilising the one or more active agents within the vial cap ensures that the one or more active agents are retained in sterile conditions, that the lyophilised one or more active agents and the diluent may be stored efficiently, and that the one or more active agents may be solubilised in a sterile and efficient manner.

主权项

1. A method of manufacturing a pre-loaded container for use in dispensing one or more active agents comprising the steps of;
providing a container, a closure having a recess, and a solution containing one or more active agents; adding a portion of the solution into the recess of the closure; covering the closure with a sealing element comprising a piston, the piston having at least one aperture to allow the recess of the closure to be ventilated during the step of lyophilisation; lyophilising the solution in the recess of the closure; sealing the closure by sealedly mounting the sealing element to the closure such that the at least one aperture of the piston is sealed, thereby sealing the recess of the closure; and adding a suitable diluent to the container and sealing the container with the closure.