Prioritizing Cleaning Validation

Published on: 
BioPharm International, BioPharm International, 2021 Biopharmaceutical Analysis eBook, Volume 2021 eBook, Issue 3
Pages: 35–37

As recent COVID-19 vaccine facility citations make clear, failure to meet cleaning and sanitization requirements puts patients, facilities, and operators at risk.

While the importance of cleaning procedures in bio/pharmaceutical facilities are well-known, recent regulatory citations suggest that pharmaceutical manufacturers and contract manufacturing and development organizations (CDMOs) may take cleaning and cleaning validation for granted. Multiproduct facilities, and particularly biopharmaceutical facilities, pose several cleaning validation challenges.

Risk-based standards for cleaning validation, established in recent years, have established a more scientific basis for cleaning practices. Taking cleaning and sanitization validation programs for granted, however, puts facilities and people at risk and increases the likelihood of costly noncompliance.


Read this article in BioPharm International’s July 2021 Biopharmaceutical Analysis eBook.

About the Author

Agnes Shanley is former senior editor to BioPharm International.

Article Details

BioPharm International
eBook: Biopharmaceutical Analysis, July 2021
July 2021
Pages: 35–37


When referring to this article, please cite it as A. Shanley, “Prioritizing Cleaning Validation," BioPharm International Biopharmaceutical Analysis eBook (July 2021).