Aseptic filling line for 131i sodium Iodide
Handling and packaging radioactive isotopes like 131I requires stringent GMP compliance to ensure safety and precision throughout the production cycle. Achieving this involves integrating specialized filling lines designed to mitigate contamination and exposure risks.
Cover the entire aseptic filling process
The Aseptic Filling Line for 131I by Comecer encompasses the complete filling process, from the receipt of raw materials to the final packaging of radiopharmaceuticals in shielded lead containers. The system adheres strictly to current GMP regulations, ensuring safe and sterile operations. Key components include a Receipt Hot Cell for initial stock handling, a Laminar Flow hood for sterile disposable introduction, and a Formulation Hot Cell for bulk product preparation. Additionally, a Loading Flowbox enables unpacking and prefilter integrity testing, while the Filling Hot Cell facilitates precise vial filling. Quality control is maintained with a QC Micro-Hot-Cell for sterility testing and inspection. Final product inspection and labeling occurs in the Inspection and Labelling Hot Cell, where activity is measured and labeled vials are safely delivered using a mechanical handling system.
Benefits
- Ensures compliance with GMP regulations
- Minimizes contamination and exposure risks
- Automated handling reduces human error
- Integrated quality control for sterility testing
- Safe final product packing in lead containers