Quality Control Laboratory

The Cyclotron and Radiochemistry Program's Quality Control (QC) Laboratory ensures the regulatory compliance of radiotracer productions. All procedures involving human use of radiotracers comply with 21 CFR Part 212, the U.S. Food and Drug Administration’s cGMP guidance for production of PET drugs, and/or the U.S. Pharmacopeia's Chapter 823 standards for PET drug production and compounding.

Our QC equipment includes:

• Agilent 7820A gas chromatographs (2) with flame ionization detector and autosampler
• Agilent 7890 gas chromatograph with thermal conductivity detector
• Thermo Ion chromatographs 1600 (2)
• Agilent HPLC 1260 chromatographs (2)
• Bioscan AR-2000 Radio-TLC
• Canberra Broad Energy Germanium Detector BE3825 system with shield
• Endosafe®-PTS for endotoxin assay
• Dose calibrator and chamber shield
• Incubators for TSB and FTM sterility tubes
• Water purification system