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Anne Marie Dixon-Heathman is the owner and president of Cleanroom Management Associates, Inc.
Traditional methods of testing cleanroom garments fail to test for dynamic conditions in the cleanroom. A holistic approach considers particulate shedding and heat load during processing, as well as the impact of laundering on garment life cycle.
Selecting the best cleanroom garments for a specific application is crucial to maintaining the integrity of aseptic processing areas. The author has developed an evaluation process, outlined in this article, that uses "real world" conditions to determine how well cleanroom garb will prevent particulate emission and maintain comfortable temperatures for operators.
eBook: Regulatory Sourcebook, March 2021
When referring to this article, please cite it as A. Dixon-Heathman, “A Real-World Approach to Evaluating Cleanroom Garments,” Pharmaceutical Technology Regulatory Sourcebook eBook (March 2021).