Recommended Best Practices for Process Monitoring Instrumentation in Pharmaceutical Freeze Drying

Recommended Best Practices for Process Monitoring Instrumentation in Pharmaceutical Freeze Drying—2017

Published:2017-02-15 Issue:7 Volume:18 Page:2379-2393
ISSN:1530-9932
Container-title:AAPS PharmSciTech
language:en
Short-container-title:AAPS PharmSciTech

Author:

Nail Steven,Tchessalov Serguei,Shalaev Evgenyi,Ganguly Arnab,Renzi Ernesto,Dimarco Frank,Wegiel Lindsay,Ferris Steven,Kessler William,Pikal Michael,Sacha Greg,Alexeenko Alina,Thompson T. N.,Reiter Cindy,Searles James,Coiteux Paul

Publisher

Springer Science and Business Media LLC

Subject

Drug Discovery,Pharmaceutical Science,Agronomy and Crop Science,Ecology,Aquatic Science,General Medicine,Ecology, Evolution, Behavior and Systematics

Link

http://link.springer.com/article/10.1208/s12249-017-0733-1/fulltext.html

Reference18 articles.

1. Hardwick LM, Nail SL, Jarman JG, Hasler K, Hense T. A proposed rationale and test methodology for establishment of acceptance criteria for vacuum integrity testing of pharmaceutical freeze dryers. Eur J Pharm Biopharm. 2013;85:236–9.

2. Li X, Nail SL. Magnetic resonance imaging of freeze drying. J Pharm Sci. 2006;95:2016–25.

3. Konstantinidis AK, Kuu W, Otten L, Nail SL, Sever RR. Controlled nucleation in freeze drying: effects on pore size in the dried product layer, mass transfer resistance, and primary drying rate. J Pharm Sci. 2013;100:3453–70.

4. Brower J, Lee R, Wexler E, Finley S, Caldwell M, Studer P. New developments in controlled nucleation: commercializing VERISEQ® nucleation technology. In: Lyophilized biologics and vaccines. New York: Springer; 2015. p. 73–90.

5. Rambhatla S, Pikal MJ. Heat and mass transfer scale-up issues during freeze-drying I: atypical radiation and the edge vial effect. AAPS PharmSciTech. 2003;4(2):117–26.

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