The classic process for the filling of pharmaceutical or biotechnological drugs into vials provides for the cleaning and subsequent sterilization of the vials as upstream processes. The vials are thereby fed to the cleaning and drying process in direct glass-to-glass contact with one another via separation and supply systems and subsequently subjected to a sterilization process. These are decisive and critical steps for the observance of the required limits for germ count and endotoxins, as well as for general particle contamination, and thus for the later quality of the final product. Direct contact of the glass vials with one another also presents an increased risk of damage, which cannot least lead to an increased risk of glass damage.

Treatment with EtO gas is a standard procedure for the sterilization of prefillable glass containers. The completely validated EtO sterilization process of the Gx® ready-to-fill vials is carried out by a contract company certified by us. Sterilization is based on validated processes in accordance with applicable standards. Sterility proofs are carried out as part of the final product approval for each batch. A COC (certificate of conformity) is created and issued for each batch.

During the filling process at pharmaceuticals customers, Gx® ready-to-use vials are unpacked step-by-step and further processed using the most modern filling and sealing technology. As with the familiar Gx RTF® syringes, the filling and sealing procedure takes place directly in the nested container without glass-to-glass contact. Or the sterile vials are removed from the nested containers and further processed conventionally in the filling line.