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20 Pharmaceutical Technology REGULATORY SOURCEBOOK MARCH 2021 P h a r mTe c h . c o m Operations garments were worn at the beginning of each test period. The results summarized in Figures 4a–c are for garments that had been worn for up to two hours. As expected, a garment that has been laun- dered only 10 cycles performed better than gar- ments laundered 50 cycles. At 50 cycles, the reus- able garments demonstrated less particulate risk than the single-use garments. All garments that 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, and it is important to ensure the reusable cleanroom pro- vider maintains a quality system that focuses on intensive inspection processes and grading sched- ule options that align to the quality requirements for product and process, cleanroom, and regula- tory requirements. Summary Many papers have been written that show the risk that cleanroom garments pose to aseptic operations. The goal of this study was to test cleanroom garment systems under conditions similar to those experienced during routine op- erations. The results of this study suggest that single-use garments can result in higher particle levels when compared to reusable garments, par- ticularly under conditions that involve vigorous operator activity. Additionally, the requirements of a reusable garment call for continued particle protection over time, suggesting that untested garments that are left in ser vice could pose a risk to operations. The garments do not show a statistically signifi- cant level of particle generation when compared 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. Figure 4a – c. Comparison of movements vs. laundry cycles. Data compared particles released during typical movements based on fabric and laundering.