Ice Fog as a Means to Induce Uniform Ice Nucleation During Lyophilization (Peer Reviewed) - The authors describe a novel means to control ice nucleation using a sterile cryogenic ice fog that is appl

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Ice Fog as a Means to Induce Uniform Ice Nucleation During Lyophilization (Peer Reviewed)
The authors describe a novel means to control ice nucleation using a sterile cryogenic ice fog that is applicable to laboratory-, pilot-, and production-scale lyophilizers.


BioPharm International
Volume 25, Issue 1, pp. 33-38

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,
.

PEER REVIEWED

Article submitted: Aug. 16, 2011. Article accepted: Oct. 18, 2011.

REFERENCES

1. M.L. Roy and M.J. Pikal, J. Parenter. Sci. Technol. 43, 60–66 (1989).

2. J.A. Searles, J. F. Carpenter, and T.W. Randolph, J. Pharm. Sci. 90, 860–871 (2001).

3. S. Rambhatla et al., AAPS PharmSciTech 5 (4), 54–62 (2004).

4. T. D. Rowe, presentation at International Symposium on Biological Product Freeze-Drying and Formulation (Geneva, 1990).


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