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.
CRP operations are monitored by UT Southwestern Medical Center's Radiation Safety Office to ensure compliance with the U.S. Nuclear Regulatory Commission's radiation safety regulations.
Our QC equipment includes:
- Agilent 7820A gas chromatograph with flame ionization detector and autosampler
- Agilent 7820A gas chromatograph with thermal conductivity detector
- Ion chromatograph 1600
- Bioscan AR-2000 Radio-TLC and imaging scanner
- 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
- Agilent liquid chromatography-mass spectrometry (LC-MS), inductively coupled plasma mass spectrometry (ICP-MS)