Dispensing of the radiopharmaceutical takes place in a vertical, laminar, down-draft hotcell achieving aseptic ISO Class 5 conditions. This dispensing hot cell has an ISO Class 6 pre-chamber that allows for the introduction of materials to the dispensing area. This hot cell is in its own cleanroom. While it is not necessarily required by the FDA and 21 CFR 212 to have a separate dispensing area in its own cleanroom, the design does has certain advantages.
While this separate cleanroom requires its own airlock and gowning rooms, it does allow this cleanroom along with space in the Quality Control room to be dedicated to future nuclear pharmacy space. Rules of Pharmacy require minimum floor and workspace areas that are dedicated to pharmacy operations and this dispensing cleanroom will form part of that dedicated space. This will be advantageous when the Facility starts to produce clinical drugs and allow for the shipping of that drug to other medical facilities within the University of Chicago Medicine group.
This dispensing hotcell will serve the two cleanrooms on the south side of the facility. A future dispensing hotcell to be installed in the north wall of this dispensing room will serve the two cleanrooms on the northside of the facility providing for multiple simultaneous drug production and backup of equipment. The hot cell was manufactured by Comecer SpA of Castel Bolonese, Italy.
Besides the dispensing hot cell, the Dispensing cleanroom also contains two laminar flow biosafety cabinets (BSC), a fume hood, and a stainless steel work table. The near BSC is used for aseptic assembly of the final product vials and associated vent needles and tubing. They are both also used as part the the Quality Control testing. pH, aloquotting samples for TLC, GC, and HPLC, and sterility sampling are performed in the far BSC. The stainless steel worktable holds a lead L-block and bacterial endotoxin testing is performed behind it using the Charles River PTS system. The fume hood is used for TLC strip preparation and if needed application of sulfuric acid as in the case of FDG production.