Rb-82 generators production plant
When producing radiopharmaceutical generators like Rb-82, maintaining strict aseptic conditions and ensuring high productivity are crucial. Additionally, handling hazardous materials safely and efficiently poses significant challenges in the manufacturing process.
Ensure sterile, high-volume rb-82 generator production
The Rb-82 Generators Production Plant by Comecer is a sophisticated facility designed for the aseptic production of Sr-82/Rb-82 generators. Comprising eight shielded isolators interconnected for seamless operation, the plant utilizes lead shielding of varying thicknesses (125mm, 75mm, 50mm) to ensure worker safety. Integrated automation systems manage the formulation, filling, and washing of generator columns, adhering to GMP and FDA requirements. The aseptic area (Class A – ISO 5) features automatic sterilization via vaporized H2O2 generators. Conveyor systems and automatic assembly stations assist throughout the process, culminating in rigorous QC and sterility testing of the final product. The plant’s design supports high productivity, enabling the production of 100 generators in an 8-hour shift, up to three times a week.
Benefits
- High productivity: 100 generators in 8 hours
- Enhanced safety with lead shielding
- Integrated automation for formulation and filling
- Automatic aseptic area sterilization
- Compliance with GMP and FDA regulations