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18 BioPharm International eBook March 2021 www.biopharminternational.com tory test methods. The goal of this testing was to assess the impact of the garment on the cleanroom during operations and to evaluate garment types under dynamic con- ditions. Two critical questions were asked: First, can you test a garment in use? Second, can you perform the testing real time during a shift without re-gowning? TEST MATERIALS AND PROTOCOL To perform this evaluation, the fol- lowing equipment, testing envi- ronment, garments, and overall protocol were established: Equipment • Body Box–Technovation Body Box System • R a ise d f lo or w it h i nter na l height of 7 f t and internal dimension of 4 ft x 4 ft • Two 2 x 4-ft high-efficiency particulate air (HEPA) filters with 99.999999% efficiency. • Thermal imaging camera (Fluke FLIR). Requirements for semi-annual cur- rent certification per ISO 14644- 1:2015 in Operational Status • Gown room–ISO 6 • Cleanroom–ISO 5 • Body Box–ISO 5 (within the cleanroom) • Particle Counter – BioTrack Model 9510-BD. Garment materials and design • Single-use fabric made with common materials (i.e., Tyvek high-density polyetheylene or its equivalent) • Reusable fabr ic made w it h Starshield ESD polyester. Garment design involved sep- arate coveralls, hoods, and boot with a front zipper and compatible goggles and gloves. Standard cleanroom gowning pro- tocol was followed. All gowning was worn over scrubs, with required hair- nets, shoe covers, beard covers, face masks, and gloves. Personnel The personnel who participated in the study were experienced work- ing in ISO-5 cleanrooms and also experienced in gowning. They per- formed their routine cleanroom activities when they were not in the body box. Protocol Subjects gowned in an ISO class-6 gown room and entered the ISO 5 cleanroom with the body box. Each of them performed the movements as indicated below. Subjects worked for a period of one hour in an ISO 5 cleanroom then re-entered the body box and performed the same test. This is a critical step —the subjects did not exit the cleanroom, they per- formed their routine job. The subjects then re-entered the ISO 5 cleanroom and worked for an additional one hour, and again re-entered the body box perform- ing the same movements. The movements are based on Institute of Environmental Science and Technolog y's (IE ST's) R P-3 requirements (1). Three movements were used during the testing: • Arm reach—Subject stands upright with arms at his or her side, crosses hands across chest touching each shoulder with hands (palms in) then extends both hands straight out in front from the shoulder with palm down. Movement is repeated for the duration of the sample. • March and touch—Subject walks in place with arms at his or her side, alternately touch- ing the hand (palm in) to the opposite shoulder and return- ing it to the side. Movement is repeated for the duration of the sample. • Sit and fold—This method is designed to produce the "bil- lowing" effect (2) that the deep knee bends call for in the stan- dard. The knee bend technique was utilized initially during the proof of concept testing but was amended to this method for ergonomic reasons. The subject starts from a stand- ing position in front of a clean- room compatible seat. Upon the start of the test sample collec- tion, the subject sits down on the seat. The arms are simultaneously raised above the head in a "Y." The arms are then placed across the chest (as in the arm reach), and the subject folds over, bringing shoulders to the knees with arms still crossed. Subject then unfolds to an upright position returning arms to the side. The 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 move- ment cycle is repeated for each of the five one-minute samples. RESULTS T he initial compar ison of fab - ric types indicates that the more vigorous the activit y, the more particles are released, w ith 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 test- ing. Results show that the partic- ulate generation rate for single use increases dramatically the longer the garment is worn. Regulatory Sourcebook Operations