GAIA V2 Peptide Labelling Fluidic Processor
The GAIA V2 is the next generation in peptide labeling, designed for radiometal-based labeling such as 68Ga (Gallium), 90Y (Yttrium), and 177Lu (Lutetium). With its compact and efficient design, GAIA V2 streamlines the labeling process, reducing both the space needed in the lab and overall costs. Its user-friendly interface and intuitive handling make it ideal for researchers working in radiopharmaceutical development, particularly for applications such as DOTA-TOC and PSMA.
Key Advantages
- Compact Design: GAIA V2 fits seamlessly into tight laboratory spaces, reducing the need for extensive room in hot cells.
- Cost-Effective: Reduces per-dose costs through minimized synthesis time, reduced decay, and no requirement for gases.
- Efficient Handling: Easy-to-use interface and single-use materials simplify the labeling process and minimize maintenance efforts.
- Versatile Compatibility: Can be connected to various generators including Gallileo, E&Z, ITG, and ITB Ithemba. Contact technical support for other generator models.
- Quick and Easy Synthesis: Pre-installed methods allow fast production, while the touch-controlled user interface ensures intuitive operation.
Main Features
- Radioactive Peptide Labeling: Efficient labeling with 68Ga, 90Y, 177Lu, and more.
- Single-Use Kits: All components in contact with reagents are disposable, reducing cross-contamination risk and fulfilling GMP standards.
- Automated Self-Testing: The system performs automated checks for reactor temperature, radio-detectors, valve gears, and pump function before each synthesis run.
- Quick Synthesis Control: Includes features like multiple radio detectors to enhance labeling processes, reduce yield loss, and improve quality control.
- Interactive Process Layout: Graphical editor for process layout and timetable, offering full control over synthesis with visual flow paths and method editing.
- GMP-Compliant: The GAIA V2 is designed for routine use in GMP production environments, with features such as audit trails, bar code readers, and write-protected data files.
Performance Specifications
- Power Requirements: 230V / 100VA
- Dimensions: 379 mm (L) x 195 mm (W) x 307 mm (H); Length with inlet/outlet: 440 mm
- Weight: Max 25 kg
- Operation Conditions: Temperature range: 10–40°C, max humidity: 70% RH
- Over-Pressure Stability: 5 bar
Components:
- Peristaltic Pump: Speed range +/- 1 to +/- 300 rpm, with lid and rotation sensors.
- Number of Valves: 3 x 5 valves for enhanced fluidic control.
- Number of Reactors: 1 reactor for efficient synthesis control.
- Radioactivity Detectors: 3 detectors for process control, and 1 detector for fractionation.
- Sensors: Includes gas pressure sensors (200 to 7000 mbar, accuracy +/- 10 mbar) and pressure sensors.
Heating and Cooling:
- Dynamic Temperature Range: 10°C to 150°C
- Heating Speed: 25°C to 100°C in less than 50 seconds
- Cooling Speed: 100°C to 30°C in less than 7 seconds
- Temperature Accuracy: +/- 1.0°C
User-Friendly Operation
The GAIA V2’s user interface is designed to be straightforward, with a touch-screen display for process monitoring. Pre-installed labeling methods allow users to run processes immediately after installation with minimal training. Additionally, GAIA V2 features color-coded connections, bar code readers, and automated error detection for hassle-free operation.
- Self-Testing Features: The system performs automated tests on key functions, ensuring operational reliability.
- Interactive Tutorials: Step-by-step video tutorials guide users through each process, increasing confidence and ease of use.
Maintenance and Service
GAIA V2 is built for long-term reliability, with minimal moving parts to reduce wear and tear. Additionally, essential components like the pump and valves can be easily exchanged, reducing downtime. Comprehensive service and warranty contracts are available, including IQ/OQ validation services performed by certified Elysia-Raytest engineers.
GMP Production and Compliance
GAIA V2 is fully compliant for use in GMP production environments. The system offers advanced features such as:
- User Access Control: For secure operation.
- Audit Trails: Ensures all operations are logged and compliant with regulatory requirements.
- Data Integrity: Write-protected files and traceable batch numbers provide complete accountability.
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.