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www.biopharminternational.com March 2021 eBook BioPharm International 19 With increased activity, the poly- ester garment (StarShield) does not show the same increase in particle generation as the single-use gar- ments under the same conditions (i.e., using the body box, identical operators, and particle counters). Results (Figure 1) suggest that the reusable Starshield ESD garments outperform Tyvek/A5. The data also demonstrate that the particulate shed-rate difference is four times higher than 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 differ- ence is a concern during operations, equipment set-up, and repairs, or interventions which require con- stant movement of the technician, as well as any operations involving limited personnel. THERMAL TESTING A c h i e v i n g w o r k e r e f f i c i e n c y u n d e r s t r e s s f u l h e a t c o n d i - tions is difficult. Over the past 5 0 ye a r s , t he i mp a c t o f he at stress on productivit y has been reported by the US Army and the National Aeronautics and Space Administration, which published g u id a nce on heat-re late d con- cerns for protective garments in t he 198 0 s. Heat load compa r i- sons for reusable and single-use cleanroom garments are show n in Figur e 2 and 3. The FLIR images were taken using a FLUKE Ti125 Thermal Imager. The equipment was operating in the manual set- ting with one reference point (+) recorded. T he manual mode of operation automatically scales the range of colors to the range seen in the image, from 15.2 °C (blue/ black) to 27.2 °C (white). SINGLE-USE VS. REUSABLE GARB The operator shown in the figures is performing the same activity in the same cleanroom on the same day with one of two different gar- ment types: a reusable polyester cleanroom garment set, consisting of coverall, hood, boots, gloves, a nd gog g les, a nd a si ng le - u se (Tyvek) garment set. The compar- ison of the images indicates that the operator's skin temperature is approximately 5 °C higher when wearing the single-use garment. One of the most common com- plaints regarding cleanroom gar- ments is that they are too warm to wear. For heat-stressed workers, a difference of 1.5 °C could result in differences in productivity. In this case, the difference is greater than three times the level that would be considered significant. The billowing effect also increases the risk of particle generation (6). If the body temperat ure is ele- vated, there is a risk of additional m ic robia l conta m i nat ion f rom personnel. The test data showed that reusable garments were 5 °C Regulatory Sourcebook Operations Figure 1. In tests, reusable garments shed fewer particles than single-use types. 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 2. In tests, multi-use garb generated less heat and particulates. Figure 3. Single-use garb generated more heat and particulates. ALL FIGURES ARE COURTESY OF THE AUTHOR.