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10 BioPharm International Quality and Regulatory Sourcebook eBook March 2022 www.biopharminternational.com In-Use Testing of Cleanroom Garments Testing cleanroom garments while in use and during daily cleanroom operations is vital for contamination control. B ecause contamination is a serious issue in clean- room operations, controlling contamination gen- erated by human operators and their clothing is a major concern (1). People disperse large num- bers of particles (i.e., skin fragments, bacteria, hair) 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 parti- cles generated by the person while not becoming a source of contamination. The garment system must therefore be able to manage the particulate and, in some cases, the microbial risk to the product and process, according to Anne Marie Dixon- Heathman, principal, Cleanroom Management Associates. An important decision that faces the manager of any clean- room is the selection of a cleanroom garment or garment system, according to Dixon-Heathman. Following up on a pre- sentation given by Dixon-Heathman at INTERPHEX 2021 on in-use testing of garments, BioPharm International spoke to Dixon-Heathman for further insight. IN-USE TEST PROTOCOL BioPharm: What are some of the reasons you decided to investigate an 'in-use' testing protocol Dixon - Heathman (Cleanroom Management Associates): People shed, and solving contamination issues in today's cleanrooms is challenging. In 2015, I published a chapter on 'Investigations for Personnel Monitoring' in the book Microbial Risk and Investigations (2). In this chapter, I performed testing of particle generation from people inside a cleanroom during operations. This testing in an ISO 5 class cleanroom showed the excessive amount of contamination, both 0.5 microns and 5.0 microns, that were generated during activities, such as standing, sitting, walking, turning, etc. The test protocol utilized 48 particle counters at heights of 1 ft–6 ft FELIZA MIRASOL Quality and Regulatory Sourcebook Quality: Cleanrooms warut - Stock.adobe.com