Rb-82 generators production plant
Ensure stringent aseptic conditions and efficient Sr-82/Rb-82 generator production with advanced automation, integrating seamless formulation, filling, and quality control processes for reliable radiopharmaceutical output.
Manufactures Aseptic Rb-82 Generators
The Rb-82 Generators Production Plant by Comecer is engineered to streamline the production of radiopharmaceuticals and comply with GMP and FDA standards. This plant features a series of shielded isolators and hot cells, facilitating aseptic operations from formulation through to quality control. Equipped with telemanipulators and automated systems, the plant handles Sr-82/Rb-82 generator column production efficiently, ensuring consistency and sterility of radiopharmaceuticals. With a capacity to produce 100 generators in an 8-hour shift, it integrates automation from filling to washing and assembly. The facility leverages automated sterilization, using vaporized H2O2, for quick turnaround while maintaining aseptic conditions. Flexible conveyor systems and assembly stations support in-line QC and sterility testing, meeting the rigorous demands of nuclear medicine and pharmaceutical industries. Comecer also offers customization options and engineering support to adapt the plant to specific production needs.
Benefits
- Ensures high sterility standards with automated vaporized H2O2 sterilization, reducing contamination risk.
- Optimizes production efficiency, achieving 100 generator units in an 8-hour shift.
- Reduces manual intervention with integrated telemanipulators and automated systems, enhancing operator safety.
- Enhances product consistency and compliance with in-line QC and sterility testing.
- Supports flexible production needs through customizable configurations and engineering support.
- Applications
- Sr-82/rb-82 generators,Gmp radiopharmacy,Radiopharmaceuticals,Aseptic manufacturing,Nuclear medicine
- End products
- Rb-82 generators,Aseptic radiopharmaceutical products,Sterile radiopharmaceutical vials,Sr-82/rb-82 generator columns
- Steps before
- Loading,Automatic formulation
- Steps after
- Automatic assembly,Quality control,Sterility testing,Finished product verification
- Input ingredients
- Sr-82,generator components,H2O2 for sterilization
- Output ingredients
- Rb-82 generators,assembled generator columns
- 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
- 8
- Type of process
- Aseptic manufacturing
- Type of shielding
- Lead 125mm / Lead 75 mm / Lead 50mm
- Automation systems available
- Automatic
- Automatic formulation
- Automatic 82Sr formulation
- Automatic filling
- Automatic filling of generator columns
- Automatic washing
- Automatic washing of generator columns
- QC In Line
- Yes
- Sterility Testing In-line
- Yes
- Productivity
- 100 generators in 8h,3 batch per week
- Class of aseptic area
- Class A – ISO 5
- Compliance
- GMP and FDA requirements
- Telemanipulators
- Yes
- Sterilization method
- Vaporised H2O2 generators
- Automation level
- Automatic / Manual
- Batch vs. continuous operation
- Batch
- CIP/SIP
- Automated Sterilization with H2O2
- Cleaning method
- Automatic Sterilization
- QC in line
- Yes
- Sterility Testing In-line
- Yes
- Biological compatibility
- Compliance with GMP and FDA requirements
- Cleanability
- Integrated vaporised H2O2 generators for aseptic sterilisation
- Corrosive resistance (e.g. acids)
- Lead shielding (125mm / 75mm / 50mm)
- Machine Footprint
- Customizable
- Number of Working Chambers
- 8
- Type of Shielding
- Lead 125mm / Lead 75mm / Lead 50mm
- Automation Systems
- Automatic 82Sr formulation,Automatic filling and washing of generator columns
- QC In-Line
- Yes
- Sterility Testing In-line
- Yes
- Telemanipulators
- Included
- Control panel type
- Automatic systems PLC-controlled
- Telemanipulators
- Integrated into hot cells
- Automatic assembly stations
- Included for generator construction
- Conveyors
- Integrated for material transport
- Vaporised Hâ‚‚Oâ‚‚ generators
- Integrated for automatic sterilization