CONCLUSION
Ice nucleation during vial freezing in lyophilization is an important process parameter that needs to be controlled. The scalable
cryogenic ice-fog technology can be used in laboratory-, pilot-, and production-scale lyophilizers to induce uniform ice nucleation
and eliminate vial-to-vial variability. Eliminating variability, in turn, can help mitigate a host of related issues and lead
to improved process and product quality.
Prerona Chakravarty, PhD*, is a project manager, and Ron Lee, PhD, is a research fellow, both in Pharmacueticals, Fine and Specialty Chemicals in Linde Gases Division, Murray Hill, NJ. Frank DeMarco is freeze drying development manger, and Ernesto Renzi is president of sales, both at IMA LIFE North America, Tonawanda, NY. *To whom correspondence should be addressed, prerona.chakravarty@linde.com
.
PEER REVIEWED
Article submitted: Aug. 16, 2011. Article accepted: Oct. 18, 2011.
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