1. A Fill Team manually dispenses sterile drug substance into sterile 1-L bottles in an ISO 5 Laminar Air Flow (LAF) Cabinet housed in an ISO 7 Fill Room. One day, a QC Associate overheard someone in the breakroom say “The bottles that were filled last week are contaminated with E. coli. I bet the Fill Technician didn’t wash his hands after using the rest room or before doing the fill”.