Automated ioflupane i-123 injection dispensing solution
Ensure precision and efficiency in radiopharmaceutical production with an advanced system for ioflupane I-123 injection dispensing. Perfect for facilities seeking enhanced sterility and speed while maintaining rigorous quality controls.
Synthesizes and Aseptically Fills Ioflupane I-123 Vials
The Automated Ioflupane I-123 Injection Dispensing Plant from Comecer is an advanced solution for radiopharmaceutical production that excels in the aseptic filling of Ioflupane I-123 vials. This system uniquely integrates automated synthesis, HPLC purification, and vial filling, ensuring precise weight control and sterility. It features multiple lead-shielded isolators that facilitate process integrity from synthesis to inspection, making it ideal for use in nuclear medicine and pharmaceutical industries. Capable of dispensing and filling at a rate of 360 vials per hour, this system reduces operator exposure through robotic buffering and decontamination with VPHP. It seamlessly combines into existing production lines, offering automated operation with semi-automatic visual inspection to ensure quality control. Designed with compliance in mind, it adheres to stringent GMP and aseptic standards, meeting the highest industry requirements while offering customization options to fit specific production needs.
Benefits
- Enhances production efficiency with high-speed vial dispensing at 360 vials per hour.
- Ensures product safety and sterility through comprehensive aseptic processing.
- Minimizes operator exposure to radioactivity with fully automated handling and VPHP decontamination.
- Integrates seamlessly into existing lines, supporting continuous operation with minimal disruption.
- Adheres to GMP standards, ensuring regulatory compliance for radiopharmaceutical manufacturing.
- Applications
- Aseptic manufacturing,Nuclear medicine,Radiopharmaceuticals
- End products
- Aseptically filled radiopharmaceuticals,Ioflupane i-123 vials,Sterile radiopharmaceutical vials
- Steps before
- Synthesis,Purification,HPLC process development
- Steps after
- Visual Inspection,Labelling,Packaging,Sterilization
- Input ingredients
- Ioflupane I-123,raw material for radiopharmaceuticals,HPLC purification components,vials,lead shielding materials
- Output ingredients
- Ioflupane I-123 Injection,dispensed vials,labelled vials,inspected and packaged vials,radiopharmaceutical products
- 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.
- Number of working chambers
- 12
- Type of process
- Aseptic manufacturing
- Type of shielding
- Lead 75mm / Lead 50mm / Lead 30mm
- Automation systems available
- Automatic synthesis and purification,automatic vial filling
- Dispensing speed
- 360 vials per hour
- Visual inspection speed
- 4 vials per minute
- Productivity
- 6 vials per minute in dispensing
- Filling volume
- 2.5 ml per vial
- Automation level
- Fully automatic
- HPLC usage
- 4 units
- Buffer capacity
- 500 vials
- Aseptic manufacturing
- Yes
- Automation level
- Fully automatic
- Decontamination
- VPHP
- Dispensing mode
- Open and closed vials
- Cleaning method
- Semi-automatic visual inspection
- Batch vs. continuous operation
- Batch
- Changeover management
- Reduction in operator radio-exposure
- Lead shielding
- Lead 75mm / Lead 50mm / Lead 30mm
- Dispensing Mode
- Open and Closed Vials
- Number of working chambers
- 12
- Type of shielding
- Lead 75mm / Lead 50mm / Lead 30mm
- Machine footprint
- Compact
- Control panel type
- Touchscreen PLC
- Integration possibilities
- HPLC,Automatic vial filling,Semi-automatic inspection
- Shielding options
- Lead 75mm / Lead 50mm / Lead 30mm