Pharmaceutical Technology - March 2021

Pharmaceutical Technology - Regulatory Sourcebook - March 2021

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16 Pharmaceutical Technology REGULATORY SOURCEBOOK MARCH 2021 P h a r mTe c h . c o m Operations ing a shift without re-gowning? Equipment. The following equipment were used for this testing: • Body Box –Technovation Body Box Syste • Raised floor with internal height of 7 ft and in- ternal 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) R e q u i r e m e n t s f o r s e m i - a n n u a l c u r r e n t certification per ISO 14644-1:2015 in Operational Status. The following were required for current certification. • Gown room–ISO 6 • Cleanroom–ISO 5 • Body Box–ISO 5 (within the cleanroom) • Particle Counter – BioTrack Model 9510-BD Garment materials and design. The following garment materials and design were used: • Single-use fabric made with common materi- als (i.e., Tyvek high-density polyetheylene or its equivalent) • Reusable fabric made with Starshield ESD polyester Garment design involved separate coveralls, hoods, and boot with a front zipper and compat- ible goggles and gloves. Standard cleanroom gown- ing protocol was followed. All gowning was worn over scrubs, with required hairnets, shoe covers, beard covers, face masks, and gloves. Personnel. The personnel who participated in the study were experienced in ISO-5 cleanroom envi- ronments, and in gowning. Cleanroom personnel performed 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 performed their routine jobs. The subjects then re-entered the ISO 5 cleanroom and worked for an additional one hour and again re-entered the body box performing the same movements. The movements are based on Institute of Envi- ronmental Science and Technology's IEST RP-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 dura- tion of the sample. • March and touch—Subject walks in place with arms at his or her side, alternately touching the hand (palm in) to the oppo- site shoulder and returning it to the side. Movement is repeated for the duration of the sample. • Sit and fold—This method is designed to produce the "billowing" effect (2) that the deep knee bends call for in the standard. The knee bend technique was utilized ini- tially during the proof of concept testing but was amended to this method for ergonomic reasons. The subject starts from a standing position in front of a cleanroom compat- ible seat. Upon the start of the test sample collection, the subject sits down on the seat. The arms are simultaneously raised above

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