LUNA GAIA GMP
Module for Therapeutic Peptide Radionuclide Labeling
The LUNA GAIA GMP Module is a cutting-edge synthesis unit designed specifically for labeling peptides, such as DOTATOC, with radioactive metals like 177Lu (Lutetium). Its compact and efficient design, along with fully automated processes, ensures minimal radioactive loss and enhanced safety, making it an essential tool for therapeutic radionuclide labeling under GMP conditions.
Key Advantages
• No Radioactive Transfer Loss: The automated hollow needle system ensures precise transfer of radioactive materials with no loss, significantly improving radiation safety.
• Single-Use Synthesis Kits: The modular design minimizes cross-contamination risks and eliminates the need for cleaning between synthesis runs.
• Compact and Efficient: LUNA is designed to fit easily into small laboratory spaces with minimal electrical connections and no need for compressed gases.
• Automated Handling: LUNA automates precursor and buffer system addition, ensuring efficient production without manual intervention.
• Seamless Integration with GAIA Software: Full control and monitoring via GAIA Control Software, including a touch-controlled interface for fast, intuitive synthesis control and process visualization.
Main Features
• Radio Metal Labeling: Primarily used for labeling peptides with 177Lu, but adaptable to other procedures that do not involve distillation or inert atmosphere conditions.
• Automated Hollow Needle System: Handles the addition of precursor, buffer, and final product transfer with saline flushing for clean, precise operations.
• Integrated Safety Features: The design ensures minimal personal radiation exposure and eliminates radioactive transfer losses.
• Single-Use Kits: Each kit is disposed of after synthesis, avoiding cross-contamination and adhering to GMP requirements.
Performance Specifications
• Power Requirements: 230V / 100VA
• Operation Conditions: 10–40°C; maximum humidity 70% relative
• Over Pressure Stability: 5 bar
• Reactor Cooling and Heating:
– Dynamic Temperature Range: 10–150°C
– Heating Speed: 25°C to 100°C in less than 50 seconds
– Cooling Speed: 100°C to 30°C in less than 75 seconds
– Temperature Accuracy: +/- 1.0°C
Software and Control
The LUNA module is controlled by the GAIA Control Software, offering comprehensive process management with a graphical editor, interactive method editor, and real-time monitoring. Users can:
• Visualize Processes: The touch-controlled interface displays full process visualization with flow paths and real-time synthesis progress.
• Quick Setup: The intuitive software design allows for fast setup and operation, ensuring users can begin production with minimal training.
• Detailed Documentation: The software records every step, including preparation and QC data, ensuring compliance with GMP regulations and maintaining data integrity with electronic signatures.
LUNA Operation
LUNA simplifies the labeling process with fully automated handling and a minimalistic design:
• Compact Construction: Fits within the GAIA main module’s working surface, which can be hinged down for easy kit installation.
• Self-Testing: The system runs a self-test before each synthesis to ensure kit integrity and proper setup, further reducing errors and downtime.
• Color-Coded Status Indicators: A light strip at the top of the unit provides color-coded information about the system’s operational status, ensuring clear visibility during the synthesis process.
Technical Specifications
• Dimensions: 300 mm (W) x 170 mm (H) x 90 mm (D)
• Weight: 5 kg
• Radioactivity Detector: Semiconductor detector for process control
• Hollow Needle System: Vertical distance of +/- 79 mm for precise reagent handling
GMP Compliance
LUNA adheres to GMP production standards, offering full user access control, audit trails, electronic signatures, and data security. This ensures that the system meets regulatory requirements for therapeutic radionuclide labeling in both research and production environments.
