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NaOAc) and 1 mL ligandsolution (2 ppm PTSM, 2% EtOH) passingftthroughaseptumintoa35-ccsyringepr@ oadedwfth28mL stenlewater. This solutionis thoroughlymixed by agitationof the syringeandinjectedasabolusthrougha0. 2pmfilter. Thegenerator is eluted twice before shipping, providing quality assurance samples, and shipped to the clinical site by overnight delivery. Complete quality assurance testing is performed the evening before the generator reaches the clinical site. Results: A total of 34 generatorshavebeenproducedandshippedto2clinicalsitesfor a phase Ill Food and DrugAdministrationstudy. The load activity on the generatorsat 8: 00 AMthe day of dinical usewas 1.7 ±0.2 GBq (46.7 ±5.6 mCi), and yield was 72% ±16%. Breakthrough of e2Zn was undetectable by high-purity germanium spectroscopy for all units. Radiochemical purity was 95.4% ±2.4%. Volume delivered, pH, sterility, and bacterial …