Aseptic filling line for 131i sodium Iodide
Ensure compliant production of iodine-131 radiopharmaceutical vials with precise aseptic filling, optimized for sterility and accuracy in every step, from formulation to packaging.
Processes and Fills Iodine-131 Radiopharmaceutical Vials
The Aseptic Filling Line for Iodine-131 by Comecer is a robust solution tailored for advanced radiopharmaceutical processing. This system excels in maintaining aseptic conditions while seamlessly integrating into your existing production workflow. It employs a step-by-step processing line, including material reception, sterilization through a laminar flow hood, formulation, and automated vial filling within shielded hot cells. Ideal for producing both diagnostic and therapeutic iodine-based vials, it enables precise control over the entire aseptic process, ensuring GMP compliance. This line supports continuous operation, bolstered by automated quality control features like prefilter integrity testing and sterility inspection within QC micro-hot-cells. Built with versatility in mind, the equipment’s durable materials withstand rigorous sterilization and decontamination processes, ensuring longevity and safety in radiopharmaceutical applications. Custom engineering support is available, allowing the system to be tailored to specific production requirements and operational scales.
Benefits
- Ensures product safety and purity with GMP-compliant aseptic processing.
- Minimizes contamination risk through automated sterile material handling.
- Enhances operational efficiency with continuous, uninterrupted production cycles.
- Supports comprehensive quality control with integrated sterility and inspection systems.
- Offers scalability and customization to meet specific production demands.
- Applications
- Liquid formulations,Gmp radiopharmacy,Radiopharmaceuticals,Pharmaceutical vials,Nuclear medicine
- End products
- Therapeutic radiopharmaceutical vials,Sterile liquid pharmaceutical vials,Diagnostic nuclear medicine vials,Iodine-131 radiopharmaceuticals,Gmp-compliant radiopharmacy vials
- Steps before
- Receipt of raw material,Formulation of bulk product,Prefilter integrity testing
- Steps after
- Sterility testing,Inspection,Labelling,Packing in shielded lead containers
- Input ingredients
- 131I stock,sterile disposables,bulk product,filling materials
- Output ingredients
- product vials,labelled product vials,shielded lead containers
- Market info
- Comecer is known for manufacturing advanced containment and isolation systems, particularly in the pharmaceutical and nuclear medicine sectors, with expertise in custom-engineered equipment, ensuring high safety and compliance standards.
- Compliance with GMP
- Strict compliance
- Hot Cell Configuration
- Receipt,Laminar Flow,Formulation,Loading Flowbox,Filling,QC Micro,Inspection and Labelling
- Automated Handling System
- Mechanical handling system for lead pot delivery
- Process Coverage
- Receipt of Material to Packing
- Batch vs. continuous operation
- Batch process
- Automation level
- PLC-controlled
- CIP/SIP
- CIP 121°C / SIP 135°C
- Cleaning method
- CIP / Manual
- Energy efficiency
- Optimized for radiopharmaceutical processing
- Integrated steps
- Raw material receipt to packing
- Workflow management
- End-to-end sterile handling
- Hot cell usage
- Multiple hot cells for different stages
- QC testing
- Sterility and inspection processes
- Density/particle size
- 0.5–2.5 g/cm³ / 50–1000 µm
- Machine footprint
- Compact
- Hot cell configuration
- Receipt,Laminar Flow hood,Formulation,Filling,QC Micro,Inspection and Labelling
- Container type
- Shielded lead containers
- Flowbox type
- Loading Flowbox
- Control panel type
- PLC / HMI
- Integration possibilities
- Modular design,scalable integration
- Footprint
- Compact design for limited space installations
- Automation level
- Fully automated with manual override