Issue link: https://www.e-digitaleditions.com/i/1354372
20 BioPharm International eBook March 2021 www.biopharminternational.com Regulatory Sourcebook Operations cooler than the single-use garments. Personnel who perspire and do not change garments when the garment is moist could risk a breach, which could allow contamination to be transmitted to the process environment through the garment or from garment billowing. All these risks must be evaluated when select- ing a garment system. Tests were performed in the body box using various t y pes of reusable cleanroom garments that had been laundered for 10, 30, and 50 cycles (Figures 4a-c). The Y axis represents particles per cubic foot/minute with a size range of 0.5 microns and larger. The X axis represents hours in use. The maximum wearing for the operator was fou r hou rs (wh ich included t he test ing a f ter t wo hou rs). New ga r ments were wor n at t he beg inning of each four-hour test per iod. As expected, a garment that has been laundered only 10 cycles performed better than garments laundered 50 cycles. Reusable garments at 50 cycles demonstrated less particulate risk than si ngle -use ga r ments. A l l ga r ments t hat were tested were "white" graded garments. The grading schedule was developed to align with IEST standards. These garments had very limited damage or repairs. Any lower-graded gar- ments would pose a high risk to the user. It is important to ensure the reusable cleanroom provider maintains a quality system that focuses on intensive inspection processes and grading schedule options that align with the quality requirements for both product and process as well as the cleanroom, and with regulatory requirements. SUMMARY Many papers have been written that show the risk of cleanroom garments to the operation. The goal of this study was to perform testing of cleanroom garment systems during routine operations. The results of the study suggest that single-use garments can result in higher particle levels when Figure 4a-c. Particulate release for fabrics and number of laundry cycles vs. hours worn, for specific operator moves. 150 100 50 0 Particles ≥ 0.5 m/min Fabric/Laundry Cycles March in Place 0 1 2 Hours in use Poly/10 Poly /30 Poly/50 150 100 50 0 Particles ≥ 0.5 m/min Fabric/Laundry Cycles Sit and Fold 0 1 2 Hours in use Poly/10 Poly /30 Poly/50 80 60 40 20 Particles ≥ 0.5 m/min Polyester/Laundry Cycles Single Arm Reach 0 1 2 Hours in use Poly/10 Poly /30 Poly/50 0 A. B. C. Garment evaluation should consider fabric, laundering history, and changes in heat load when operators are performing their jobs.