Synthesis and dispensing hot cell for radiopharmaceuticals
In radiopharmaceutical production, ensuring sterile conditions and precise dosage is paramount. Inefficient handling of radioactive substances poses significant safety and compliance challenges within GMP standards.
Combine synthesis and dispensing in sterile conditions
The BBST COMBO Hot Cell from Comecer is a specialized synthesis and dispensing hot cell designed for radiopharmaceutical production. This system integrates a shielded housing for synthesis modules with a fractionation system, all maintained under cGMP-compliant sterile conditions. Featuring a main shielded chamber (dispensing area) with Class “A LAF” by a combined system “air tight – laminar flow,” the unit includes a pre-chamber (Class B), a shielded synthesis area (Class B), and a solid and liquid waste collection system. Advanced functionalities such as airtight connections for radioactive fluids, high sensitivity tele-pliers, and an automatic pressure adjustment system enhance operational safety and efficiency. The touch screen controls for both the hot cell and dispensing system simplify operation, while the dose calibrator (available in 2 Ci or 20 Ci versions) ensures accurate dosage. VPHP connections and a semi-automatic bubble point test (touch screen controlled) add further convenience and compliance with sterilization standards. Equipped with the Illuminate™ MI platform, this hot cell offers real-time performance data to optimize production processes.
Benefits
- Ensures sterile conditions in compliance with cGMP
- Integrated synthesis and dispensing reduce handling errors
- Advanced safety features enhance operational security
- Accurate dosage with dose calibrator options
- Real-time performance data with Illuminate™ MI platform