Publication

Article

BioPharm International

BioPharm International, 2021 Biopharmaceutical Analysis eBook
Volume2021 eBook
Issue 3
Pages: 35–37

Prioritizing Cleaning Validation

Author(s):

Agnes Shanley

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

Prioritizing Cleaning Validation; Image: bankrx - Stock.adobe.com

bankrx - Stock.adobe.com

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

Citations

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

Articles in this issue
Kateryna_Kon/Stock.adobe.com – complex biomolecules pose unique challenges for drug developers seeing analytical characterization.
Complex Biomolecules Require Analytical Evolution
tilialucida/Stock.adobe.com – bioanalytical method development is important to establish early on in the drug development life cycle.
Best Practices for Analytical Method Validation: Study Design, Analysis, and Acceptance Criteria
Data Integrity Associated with Analytical Testing
Data Integrity Considerations for Vendor-Generated Data Associated with Analytical Testing
Detecting Residual HCPs Demands a Holistic Approach; image: eplisterra - Stock.adobe.com
Detecting Residual HCPs Demands a Holistic Approach
HCP Analysis with TIMS-MS
Increasing the Depth and Reliability of HCP Analysis Using TIMS-MS
Robert Kneschke/stock.adobe.com – MMS is a recent innovation that can help improve analysis of secondary protein structure.
Improving IR Spectroscopy as a Tool for Biopharmaceutical Analysis

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