A comprehensive battery of tests including filter integrity, downflow, bleed airflow, light intensity and noise level was carried out to verify the performance of the Esco Pharmacon Downflow booth. Booth performance was established to be within industry accepted and manufacturer’s criteria. A surrogate powder test involving the hand transfer of 25kg of lactose, in accordance with the ISPE Good Practice Guidelines, was then carried out. Multiple air sampling positions were strategically located at the operator breathing zone, inside, and outside the booth. Laboratory analysis of the sampling discs recovered indicated that booth performance was excellent, with all sampling locations, including the critical operator breathing zone, reading significantly less the industry-accepted criteria of 100 μg/m3.
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