Using Closed-Vial Technology in Aseptic Filling - Pharmaceutical Technology

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Using Closed-Vial Technology in Aseptic Filling
Closed-vial technology is an alternative to traditional glass vial filling that reduces the risk of contamination for the patient, simplifies the filling process, and provides easier handling for healthcare providers.


Pharmaceutical Technology
Volume 36, Issue 5, pp. s36-s40

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 l'Exportation (AWEX). Initial technology has been licensed by Medical Instill Technologies.

Benot Verjans is chief commercial officer at Aseptic Technologies, 7 rue C. Hubert, B-5032 Gembloux, Belgium, tel. 32 81 409 417,
.

References

1. R.P. Vonberg and P. Gastmeier, J. Hosp. Infect. 65 (1), 15-23 (2007).

2. J. Lysfjord, Ed. Isolators for the Aseptic Manufacture of Parenterals, Practical Aseptic Processing – Fill and Finish (Davis Healthcare International Publishing, River Grove, IL, 2009), pp. 247-272.

3. B. Verjans, J. Thilly, and C. Vandecasserie, "Aseptic Processing" supplement to Pharm. Technol. 29, s24–29 (2005).

4. J. Thilly, D. Conrad, and C. Vandecasserie, Pharm. Eng. 26 (2), 66-74 (2006).

5. B. Verjans and C. Reed, Biopharm. Intl. 25 (3), 46-58 (2012).

6. B. Verjans, "Innovation in Aseptic Processing: Case Study through the Development of a New Technology," in Advanced Aseptic Processing Technology, J. Agalloco and J. Akers, Eds. (InformaUSA, New York, 2010), pp. 438-444.

7. Aseptic Technologies, "Closed Vial Filling System" http://www.aseptictech.com/aseptic/en/8908-closed-vial-filling-system.html (accessed April 2, 2012).

8. J. Thilly and Y. Mayeresse, "Advances in Sterile Manufacturing and Aseptic Processing" supplement to Pharm. Technol. 32, s38–42 (2008).

9. FDA, Advisory to Drug Manufacturers: Formation of Glass Lamellae in Certain Injectable Drugs (Silver Spring, MD, Mar. 2011).


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