Conclusion
Closed-vial technology can provide a safer solution for the patient, in which the permanently closed container reduces the
risk of external contamination, and an easier solution for the pharmaceutical manufacturer, in which ready-to-fill containers
eliminate preparation steps. It can be used for any classical aseptic filling product. In addition, highly potent drugs
(e.g., cytotoxics and immune-modulating drugs) and biohazard products (e.g., recombinant viruses) can benefit from the reduced
breakage and spillage risks in the closed-vial technology. Other products that can benefit are lyophilized products, products
that are susceptible to adhesion on glass, expensive drugs that can benefit from lower residual volume and lower breakage
risk, and products with limited differentiation (e.g., generic drugs) in which the closed vial offers a solution to end-users.
Closed-vial technology can also improve production capacity, and can be useful for setting up local filling from global bulk
production. Some companies are investigating closed-vial technology in order to avoid issues with glass (e.g., delamination)
(9).
Regulatory authorities appear to be open to innovations supported by a clear scientific rationale, as demonstrated by the
acceptance of closed-vial technology for a pneumococcal vaccine by the European authorities in July 2011 (GSK Biologicals,
Synflorix). A key driver for the approval was that the container is produced in an ISO8 environment but is kept permanently
closed, which significantly reduces the risk of contaminant entry.
Acknowledgments
Aseptic Technologies benefits from grants given by the Region Wallonne and the Agence Wallone à l'Exportation (AWEX). Initial
technology has been licensed by Medical Instill Technologies.
Benoît Verjans is chief commercial officer at Aseptic Technologies, 7 rue C. Hubert, B-5032 Gembloux, Belgium, tel. 32 81 409 417, benoit.verjans@aseptictech.com
.
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