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In-Use Testing of Cleanroom Garments
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In-Use Testing of Cleanroom Garments
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Pharmaceutical TechnologyPharmaceutical Technology, Regulatory Sourcebook, March 2022
Volume 2022 eBook
Issue 1
Pages: 24–26, 39
Testing cleanroom garments while in use and during daily cleanroom operations is vital for contamination control.
Warut/Stock.adobe.com
Contamination is a serious issue in cleanroom operations, and controlling contamination generated by human operators and their clothing is a major concern. People disperse large numbers of particles that vary in number from person to person and over time. Thus, cleanroom garments must be designed to protect the environment and the process by containing the particles generated by the person while not becoming a source of contamination. An important decision that faces the manager of any cleanroom is the selection of a cleanroom garment or garment system, according to Anne Marie Dixon-Heathman, principal, Cleanroom Management Associates. Following up on a presentation given by Dixon-Heathman at INTERPHEX 2021 on in-use testing of garments, Pharmaceutical Technology spoke to Dixon-Heathman for further insight.
Read this article in Pharmaceutical Technology’s March 2022 Quality and Regulatory Sourcebook eBook.
About the author
Feliza Mirasol is the science editor for Pharmaceutical Technology.
Article Details
Pharmaceutical Technology
eBook: Quality and Regulatory Sourcebook, March 2022
March 2022
Pages: 24–26, 39
Citation
When referring to this article, please cite it as F. Mirasol, “In-Use Testing of Cleanroom Garments," Pharmaceutical Technology Quality and Regulatory Sourcebook eBook (March 2022).
Articles in this issue
Common FDA 483 Observations for Combination Products
Facilitating Biopharma Continuous Manufacturing
In-Use Testing of Cleanroom Garments
How a Lack of Critical Thinking is Hindering Regulatory Compliance
A Method Validation Framework for Combination Products
Contextualizing Computer Validation
Supply Chain Considerations for Ensuring Quality
DSCSA’s Next Big Hurdle
Remote Inspections - Lessons Learned
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