During regular freeze-drying in vials you still have the implication of product loss and fly-out. In addition, the staff and product are under contamination risk.
Further, aseptic development and/or manufacturing for clinical studies is difficult and expensive to achieve.
The Teclen® Lyoprotect® Solution
A tray (or frame) is used to accommodate the filled vials. These are arranged in the middle of the tray, and the stoppers are in the drying position. Open space in the tray should be filled with empty vials. The vial/tray assembly is placed into a Lyoprotect® Bag, which is closed and secured with the closing stick.
If aseptic criteria must be met, filling of vials, placement and closure of the Lyoprotect® Bag need to take place under a laminar flow / at a work bench. All required accessories (vials, stoppers, bag etc.) must be sterile. When the bag is closed, the assembly can be moved to a freeze-drier in the facility.
When the drying process is finished, the vials are securely closed with the stoppers. This is done within the freeze-drier by lowering the shelves. The flexible materials of the Lyoprotect® Bag follow the movements and mechanical loads when the stoppers are pushed in. If decontamination of the outside of the vials is needed (e.g. H2O2), this can be done with the bag still in place. After decontamination you can remove the closed vials for crimping.
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