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Pharmaceutical Technology REGULATORY SOURCEBOOK MARCH 2021 21 to the laundry number of cycles. The multiple process Starshield ESD garments show less than 50% of the new single-use shed rate. In addition, single-use (Ty vek) garments can result in a sig- nificant increase in the temperature experienced by the operator, potentially resulting in overheat- ing and increased particulate and microbial risk. Full risk assessment required In short, users of cleanroom garments must care- fully assess all potential benefits and risks when selecting a garment system. Despite study find- ings, there are applications that support the use of single-use cleanroom garments (e.g., for opera- tions in areas of facilities in which containment poses an especially critical risk). Making an informed decision requires under- standing the limitations of published laboratory test data, and awareness of data on current fabrics and how they will perform during use. Testing should assess data on fabrics, garment system de- sign and use, and wear testing to determine which gowning system can best meet contamination- control requirements in the intended application. References 1. Institute of Environmental Sciences and Technolog y (IEST) Recommended Practice (RP)-003, Garment Systems Consid- erations for Cleanrooms and Other Controlled Environments, November 2011. 2. ISO, "ISO 11607: Sterilization of Healthcare Products: Packag- ing for terminally sterilized medical devices," iso.org, February 2019. 3. A. Dixon, Microbial Risk and Investigations, Chapter 5, edited by K.Z . McCullough and J. Moldenhauer, (DHI Publishing LLC), 2015. 4. W. W hy te, a nd P.W. Bai ley, The Journal of Environmental Science;March/April:43–49 (1985). 5. B. Reinmuller, and B. Ljungqvist, Journal of Pharmaceutical Science and Technology, 114-125 (2003). 6. D. S. Ensor, J.M. Elion, and J. Eudy, Journal of the IEST, 24-32 (2001). PT • Webcasts • Digital Editions • Whitepapers • Videos • News updates • And more! ONLINE LEARNING Visit our website for the latest e-learning tools in the bio/pharmaceutical industry. Visit us at pharmtech.com PharmTech_eLearning_Ads_072120.indd 1 PharmTech_eLearning_Ads_072120.indd 1 7/21/20 9:52 AM 7/21/20 9:52 AM