To provide the related advantages of the Crystal^® Technology to the lyophilized products, Aseptic Technologies developed a radically innovative solution to perform freeze drying in the Closed Vials. 

The main steps of the process are:

• Piercing and filling of the Closed Vial (but no laser re-sealing), piercing trace is naturally re-closed thanks to elastomer self sealing capability, so vials are “closed” during their transfer to the freeze dryer;

• Fitting of a “Penetrator”, with a funnel shape, on top of the Closed Vial;

• Loading of the closed vials in the lyophilization equipment:

• At the start of the cycle, shelves are lowered to push down the “Penetrator” which re-open the stopper at the piercing trace, the “Penetrator” being maintained in that position by the shelve during the all lyophilization cycle;

• Lyophilization is made across the re-opened trace;

• At the end, shelves are lifted up and the vials naturally re-close thanks to the resilience of the stopper, which also pushes up the “Penetrator”;

• “Penetrator” is taken away, stopper is re-sealed with a laser beam and the vial is capped.

Freeze-drying performed in the Closed Vial shows results comparable to glass, with moisture below 1% after secondary drying.

In addition to the Closed Vial advantages for liquid, using Closed Vial for freeze drying actively prevents from several common issues in lyophilization such as vial breakage (they are already closed and roughly unbreakable), stoppers sticking on shelves at the end of the cycle (the stopper never touches the shelve), lifted stoppers before crimping (the stopper is already secured), ...