Occasionally, containment devices must be made a bit more complex in order to simplify the process taking place inside. Here, a powder ingredient can be manipulated in a 2- stage process involving a Mettler analytical balance and a Senco FC202 glass-jacketed reactor using a dual operator glove box workstation with balance enclosure.
This containment device offers personnel protection during a 2-stage, 2-person process. The hazards and exposure risks of both stages of the process are significant. Complete containment is needed at all times. Removal of product before the process is completed is out of the question.
The client required an enclosed weighing and mixing process involving the manipulation of High Potency Active Pharmaceutical Ingredients (HPAPI) in powder form. The first step of the process was to prepare a weighed powder sample of prescribed mass using a Mettler-Toledo XS204 analytical balance. This prepared sample was then transferred into a Senco FC202 reactor for mixing with a solvent. Operators were to be protected from dermal exposure and respiratory exposure. Operator breathing zone concentration of the HPAPI was limited to ten micrograms per cubic meter of air (<10 ug/m3) expressed as an 8-hour Time Weighted Average (TWA).
FSI determined that a pass-thru chamber between the weighing enclosure and the reactor enclosure would aid in a simpler process flow and prevent loss of product during transfer. The chamber housed a process where Operator 1 (left) transferred weighed product from the left enclosure to Operator 2 on the right. Operator 2 then manipulated the Senco reactor using the 2×2 glove port design on the left side of the enclosure. The pass-thru chamber combined with the 57” [1452mm] height and 2×2 glove port design allowed for safe and efficient completion of the process. Gloves are either of Butyl or CSM. Two ball valves connections are on the enclosure exterior, enabling nitrogen or compressed air addition.
The weighing enclosure on the left featured a top – mounted fan / filter housing which provides single-HEPA filtration and removal of airborne product from the interior of the enclosure. The reactor glovebox on the right featured a lateral flow design, using a side- mounted inlet HEPA filter (left) and a top-mounted inlet HEPA. The two inlet filters work in conjunction to move air laterally across the reactor and into the Single-HEPA filtrated fan / filter housing on the top-right of the enclosure. Exhausted air on both sides of the enclosure system may be connected to house exhaust and/or recirculated into the room.
If you have any questions regarding this containment array, please contact Flow Sciences, Inc. at (800)-849-3429 or send an email to [email protected].
