The Crystal^® Technology is a very attractive alternative solution to the classic operation with glass vials.

The concept of filling pre-sterilized Closed Vials is based on high technology compact equipment that use standard validation concepts and significantly reduce the total cost of ownership.

Different equipment have been specifically developed, to meet the needs of research lots manufacturing, clinical and small production batch filling and large capacity manufacturing.

The first Ready-to-Fill Closed Vial that behaves as an isolator.

Different Closed Vials have been developed, allowing filling volume from 0.1 to 50 ml.

Vial bodies and stoppers are molded and assembled by robots in a ISO 5 clean room. The body is made of Cyclo-Olefin Copolymer (COC) of very high purity and stopper is made of a proprietary Thermo-Plastic Elastomer (TPE).

Once closed, vials are conveyed to a ISO 8 clean room for final assembly and inspection.

Vials are then packaged, double wrapped in PE bags and gamma sterilized.

Thanks to the materials used and the manufacturing process, the Ready-to-Fill Closed Vials:

o allow the elimination of the vial washing, sterilization and stoppering operations;

o ensure lower particle presence;

o avoid siliconization as hydrophobic materials are used;

o are compatible with particle inspection, labeling and packaging equipment;

o are light, stable, unbreakable and highly transparent;

o present a very good moisture barrier;

o present a low leachable profile;

o show a very good resistance to acids, alkalis and polar organic solvents;

o demonstrate excellent biocompatibility and purity.

Ready-to-Fill Closed Vials are produced by third parties, several suppliers being or to be set up around the world, ensuring multi-source supply.