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Pharmaceutical Technology REGULATORY SOURCEBOOK MARCH 2021 17 the head in a "Y." The arms are then placed across the chest (as in the arm reach), and the subject folds over bringing shoulder to the knee with arms still crossed. The subject then unfolds to an upright position return- ing arms to the side. These movements are repeated from the seated position until the end of the one-minute sample collection, at which point the subject returns to the standing position. This movement cycle is repeated for each of the five one-minute samples. Results The initial comparison of fabric types indicates that the more vigorous the activity, the more par- ticles are released, with the single-use garment emitting the highest level of particle count. This result was statically significant and resulted in a local degradation of the ISO 5 cleanroom under the most active conditions. Data analysis The number of samples taken far exceeds the level found in any publication for this type of testing. Results show that the particulate gen- eration rate for single use increases dramatically the longer the garment is worn. In addition, with increased activity, the polyester garment (StarShield) does not show the same increase in particle generation as the single-use garments under the same conditions (i.e., using the body box, identical operators, and particle counters). Results (Figure 1) suggest that reusable Starshield ESD garments outperform Ty vek/A5. The data also demonstrate that the particulate shed-rate difference is four times higher for single-use garments during continuous movements. Many operations in cleanrooms require the operator to move from area to area, or from one end of a line to another. This extreme difference is a concern during operations, equipment set-up, repairs, or interventions that require the technician to move constantly, as well as any operations that involve a limited number of personnel. 250 200 150 100 50 0 Particles ≥ 0.5 m/ft 3 Particles vs Activity Sit and Stand Arm Reach March in Place Relative Activity Low to High Single Use Reusable A. Figure 1. Data suggest that reusable garments shed fewer particulates than single-use types. Figure 2. Heat tests show that reusable cleanroom garb (shown) provides lower heat load and particle shedding than single-use garments. The number shows heat load. ALL FIGURES ARE COURTESY OF THE AUTHOR.