Abstract
Cell processing facilities should implement and maintain a program of environmental monitoring regardless of whether product manufacturing occurs in an unclassified laboratory space or in a Class 10,000 cleanroom. Classification of space will, however, necessitate that there is documentation to verify that the specific classification is maintained on an ongoing basis. In facilities that are unclassified, the aim of the environmental monitoring program is primarily to demonstrate that conditions are appropriate for operations, and that the risk of possible contamination and cross-contamination is eliminated or minimized. This chapter discusses the development and implementation of an environmental monitoring program.
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Useful Literature
cGMP in manufacturing, processing, packing, or holding of drugs and finished pharmaceuticals. Title 21 Code of Federal Regulations, Parts 210 and 211.
Human cells, tissues and cellular and tissue-based products. Title 21 Code of Federal Regulations, Part 1271.
Guidance for Industry: CGMP for Phase 1 Investigational Drugs. Center for Biologics Evaluation and Research. Food and Drug Administration, July 2008.
Microbiological evaluation of cleanrooms and other controlled environments. United States Pharmacopeia General Chapter <1116> 2008.
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Acknowledgments
The authors are grateful to the staff of the CAGT for their help in the preparation of this article, and especially to Carlos Lee and Crystal Silva-Lentz for their suggestions and the photographs.
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© 2009 Springer Science+Business Media, LLC
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Gee, A., Lyon, D. (2009). Environmental Monitoring. In: Gee, A. (eds) Cell Therapy. Springer, Boston, MA. https://doi.org/10.1007/b102110_13
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DOI: https://doi.org/10.1007/b102110_13
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