A Robust, Automated Karl Fischer Titration System - Pharmaceutical Technology

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A Robust, Automated Karl Fischer Titration System
The authors developed a robust, automated system to conduct Karl Fischer moisture assays for lyophilized products.


Pharmaceutical Technology
Volume 33, Issue 11, pp. 52-60

Conclusion

The authors have demonstrated a system that can perform Karl Fischer titration unattended. This instrument is fully validated for use in activities such as lyophilization-cycle development, technology transfer between various manufacturing sites, and manufacturing-discrepancy investigations.

Although the platform upon which this system is based is highly customizable and versatile, the authors decided to sacrifice functionality in favor of robustness. As a result, this instrument requires minimal training for operator proficiency, requires little maintenance, and has seen heavy use. Overall, the instrument it has been a cost-effective tool that saved labor, time, and money.

Acknowledgments

The authors would like to thank M. Joyce, D. Lawrence, D. Mehrwein, C. Buruel, K. Kifle, A. Gonzales, and P. Hearne for suggestions and help with system validation.

Philippe Lam* is a senior engineer for pharmaceutical process research and development at Genentech, 1 DNA Way, South San Francisco, CA 94080, tel. 650.225.7002, fax 650.225.3616,
. Mike Nariman is a senior systems architect at AB Controls.

*To whom all correspondence should be addressed.

Submitted: Dec. 4, 2008. Accepted: Feb. 19, 2009.




What would you do differently? Submit your comments about this paper in the space below.

References

1. FDA, Guideline for the Determination of Residual Moisture in Dried Biological Products (Rockville, MD, Jan. 1990).

2. E. Scholz, Karl Fischer Titration, (Springer-Verlag, Berlin, 1984).

3. Mettler–Toledo, "Fundamentals of the Volumetric Karl Fischer Titration," (Mettler–Toledo, Columbus, OH, 1999), p. 42.


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