BioPharm International - March 2021

BioPharm International - Regulatory Sourcebook - March 2021

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www.biopharminternational.com March 2021 eBook BioPharm International 21 Regulatory Sourcebook Operations compared to reusable garments, particularly when operators are p e r for m i n g v i gor ou s ac t iv it y. Additionally, the requirements of a reusable garment call for contin- ued particle protection over time. Untested garments that are left in service may pose a contamination risk to aseptic operations. The garments do not show a sta- tistically significant level of par- ticle generation when compared to the number of cycles. The mul- tiple process Starshield ESD gar- ments show less than 50% of the new single-use shed rate. In addi- tion, single-use Ty vek garments can result in a significant increase in the temperature experienced by the operator, potentially resulting in overheating and an increased pa r t ic u late a nd mic robia l r isk. In short, users of cleanroom gar- ments must caref ully assess all potential benefits and risks when selecting a garment system. Despite study findings, there are applications that support the use of single-use cleanroom gar- ments (e.g., for operations in areas of facilities in which containment poses an especially critical risk). Making an informed decision requires understanding the lim- itations of published laboratory test data, and how data on current fabrics may translate into actual performance during use. Data on fabr ics, gar ment system desig n and use, and wear testing must be assessed to determine which gown- ing system can best meet contami- nation-control requirements in the intended application. REFERENCES 1. The Institute of Environmental Sciences and Technology (IEST)Recommended Practice (RP)-003, Garment Systems Considerations for Cleanrooms and Other Controlled Environments, November 2011. 2. ISO, "ISO 11607: Sterilization of Healthcare Products: Packaging 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. Whyte, and P.W. Bailey, "Particle Dispersion in Relation to Clothing," 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). BP Selecting the best cleanroom garments requires thorough risk assessment and understanding of data. Connect with BIOPHARMINTERNATIONAL.COM Twitter.com/BioPharmIntl LinkedIn.com/company/ BioPharm-International Sign up for our eNewsletters Get the latest news, research, and trends in the biopharmaceutical industry delivered straight to your inbox by signing up. BP_Social_HouseAds_101420.indd 2 BP_Social_HouseAds_101420.indd 2 10/14/20 2:57 PM 10/14/20 2:57 PM

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