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, plam@gene.com
. 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.
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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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