Process for the preparation of a container closed under sterile conditions and containing lyophilized material

Claim 1

In a process for preparing and packaging a lyophilized material by the steps of filling a container with the material to be lyophilized, loosely closing said container with a rubber stopper, introducing the loosely-stoppered container with the material in the container into a lyophilization apparatus, which apparatus is maintained under sterile conditions, lyophilizing the material in the container, pressing the rubber stopper into the container while the container is in the lyophilization apparatus, whereby said container is sealed, and then removing the sealed container from the lyophilization apparatus, the improvements wherein (1) said container has an external circumferential bead thereon, (2) a snap-on closure cap having an internal circumferential groove sealably engageable with said bead on said container is also loosely placed on said container over said rubber stopper before the loosely-stoppered container is introduced into said lyophilization apparatus, and (3) said closure cap is simultaneously pressed into snap-on sealing engagement with said container, over said rubber stopper, as said rubber stopper is pressed into the container, whereby said container is provided, under sterile conditions, with a snap-on closure cap over said rubber stopper.