Evaluation of Containment Ventilated Enclosure Performance in Absence of Negative Pressure Containment Secondary...

The purpose of this study was to evaluate the efficacy of a containment ventilated enclosure on preventing powder exposure to surrounding areas during a high-particle generating compounding procedure in absence of a negative pressure compounding secondary engineering control. Air samples were collected under actual compounding conditions to assess compounder and room exposure to estradiol powder. Samples were collected from several locations. The entire compounding process took place in a containment ventilated enclosure after assessing performance characteristics via velocity and smoke sampling. The particle generating compounding process consisted of weighing, multiple transfers, trituration, and capsule filling. Compounding procedures were performed by three different compounders. The laboratory detection limit for estradiol was determined, and collection parameters were targeted to ensure adequate samples were obtained to prevent false negative results. Sampling time for each compounder ranged from 24 minutes to 38 minutes. All samples collected during compounding procedures showed less than detectable amounts of estradiol. Observation of the compounding procedure showed notable potential particle generation during the compounding procedure, including spills and vigorous jostling of compounding equipment prior to encapsulation. Despite a significant potential for particulate generation inside the containment ventilated enclosure, no estradiol was detected outside of the enclosure. These findings suggest that powder chemical exposure to the compounder is minimal when using a properly certified containment ventilated enclosure. The findings also show a lack of exposure of the room to aerosolized estradiol even when using a neutral containment secondary engineering control.