The biggest challenge with automation of radio-pharmaceutical QC is that it requires a set of very different tests which rely on different pieces of equipment or individual manual procedures. Trace-Ability has solved this challenge by focusing on the answers the tests need to provide. Rather than developing new tools to carry out known tests, we have developed new tests that can be run on a single known tool and yield the needed answers. The tool is a plate reader, all tests are based on assays that yield optical signals measurable by the plate reader.
Tracer-QC system consists of a plate reader with a pipetting robot on top. It is enabled by innovative consumable kits. The user inserts kits A and B into the instrument and adds a single PET tracer sample to Kit B. The pipettor then mixes this sample with reagents in kit B and moves the resulting mixtures to Kit A. Fully loaded Kit A then enters the plate reader to measure optical signals that are generated by interactions of the sample with either reagents from Kit B or features of Kit A. The signals are interpreted as measurements of all required QC parameters and complied into a comprehensive report by 21 CFR Part 11-compliant software. Once the process is over, the kit can be removed and the system is ready for the next procedure because the sample or reagents never come in contact with the plate reader.
Tracer-QC allows complete hands-free operation from a single sample to a full QC report.
1. Add the sample and consumables
User installs three consumables and adds the product sample.
Tracer-QC Robot mixes and dispenses the sample
The pipetting robot mixes the sample with specific reagents and dispenses them to the analysis plate.
2. Initiates analysis
User initiates the analysis using the software
Tracer-QC Reader analyses the optical signals.
The reader then analyses their optical characteristics against a set of predefined and validated reference specifications.
After approximately 30 minutes a single page report on up to 10 QC parameters is delivered.
3. Collect the report
The pipetting robot mixes the sample with specific reagents and dispenses them to the analysis plate
Features & Benefits
Ease of Compliance
• No room for missing a process, record or signature
• Objective measurements with reference to standards and without any human interaction
• Data flow from measurement to batch record
— Completely traceable
• Regular automated suitability testing with permanent record
• 21 CFR 11 compliant software with access control
• No cross-contamination (samples never leave disposable kit)
• Ease of audit (internal or FDA) – instantaneous data retrieval
Efficiency and Safety
• 1 electronic report with all QC results, automatically generated
• Rapid QC results
• Increased throughput (to enable scale-up)
• Reduced risk of radioactive spills and contamination
• Reduced personnel exposure
• No cleaning or equilibration required (disposable kit)
• Inventory reduction (tracking individual expiry dates of multiple supplies/standards)
• Process standardization across sites and/or products
• Fewer and less skilled personnel
• Faster, cheaper training
• Faster, cheaper audits
• Remote record access/auditing
• Avoid cost of addressing 483’s
• One machine to maintain
• Estimated net savings ~$26,000/year for FDG production (most common tracer)
• Estimated net savings of $56,000/year for each additional tracer beyond FDG
• 34 cm (W), 98 cm (H), 67 cm (D)
• Takes up as much room as a typical GC
• Platform for easy addition of other tracers
• Single mode of detection for all tests
• Sample never touches the instrument
• Single use, completely disposable path