What will be discussed:
- Factors to consider when buying a Ge-68/Ga-68 generator (including risk assessments)
- How do I procure a Ga-68/Ge-68 generator? From which supplier? What size of generator
- Which radiopharmaceuticals can I produce?
Do I buy a synthesis module, or use kits to manufacture Ga-68 products?
- What other equipment do I need (HPLC, LAL testing, hot cell/isolator, etc)?
Do I need to consider any modifications to my current equipment?
- How many staff do I need to start a Ga-68 project?
- How do I establish a training programme for the staff involved?
- How do I write an SOP(s) for Ga-68 manufacturing?
- How can Ga-68 manufacturing affect my radiopharmacy’s QMS (quality management system)?
- How do I implement a validation plan for each aspect of Ga-68 work?
- How do I elute a generator? What tests do I do on the eluate?
- How do I manufacture a Ga-68 radiopharmaceuticals with a synthesis module? What can go wrong?
- What quality control steps do I take after manufacture of Ga-68 radiopharmaceuticals?
- When is a Ga-68 radiopharmaceutical ready for parametric or full release?