In-Depth Validation of Closed-Vial Technology - The authors describe a validation master plan for closed-vial filling technology. - BioPharm International

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In-Depth Validation of Closed-Vial Technology
The authors describe a validation master plan for closed-vial filling technology.


BioPharm International
Volume 25, Issue 9, pp. 30-42

CONCLUSION

Developing a new technology for filling injectable products requires an in-depth validation plan to ensure that such technology meets all regulatory requirements and provides the necessary features to protect and conserve the product. This article has shown that the closed-vial technology satisfies all requirements according to regulatory authorities. This article describes a useful structure of investigation to follow to prove suitability for drug approval when developing a new container (or of a new part of container).

These data have been well received by the European authorities to support approval of Synflorix, a vaccine from GSK Biologicals against pneumococcal infections that has been approved in all European countries.

ACKNOWLEDGMENTS

Aseptic Technologies receives grants from the Region Wallonne and from the Agence Wallone à l'Exportation (AWEX). Technology has been licensed by Medical Instill Technologies.

Benoît Verjans, PhD*, is chief commercial officer, Anne Glibert is in quality control, and Patrick Baleriaux is chief executive officer, all at Aseptic Technologies, Gembloux, Belgium. *To whom correspondence should be addressed,
.

REFERENCES

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

2. B. Verjans, J. Thilly, and C. Vandecasserie, C., Aseptic Processing, supplement to Pharm. Tech. 29, S24–S29 (2005).

3. J. Thilly, D. Conrad, and C. Vandecasserie, Pharmaceutical Engineering 26, 66–74 (2006).

4. B. Verjans and C. Reed, BioPharm Int. 25 (3), 46–58 (2012).

5. B. Verjans, Pharm. Tech. Eur. 24 (6) 49–55 (2012).

6. "Ozone," http://en.wikipedia.org/wiki/ozone/, accessed Aug. 2012.

7. Jiang et al., PDA J. Pharm. Sc. Technol. 61, 441–451 (2007).

8. B. Verjans et al., Pharm. Tech. 31 (4), 184–195 (2007).


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