A radical new solution for quality control of PET radiotracers.
The Tracer-QC is a completely automated solution to reporting on 10 QC tests associated with PET and SPECT radiotracers, utilizing only an optical plate reader, a pipetting robot and three simple-to-handle consumables.
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
- No cross-contamination (sample never leaves the disposable kit)
- Ease of audit (internal or FDA) – instantaneous data retrieval
- Cumulative QC cost reduction of around 30% or more
- Fewer and less skilled personnel
- Faster, cheaper training
- Faster, cheaper audits
- Remote record access/auditing
- Minimize the cost of addressing 483’s by around 84%
- One analytical instrument to maintain
- 1 electronic report with all QC results, automatically generated
- Rapid QC results
- Increased throughput (to enable scale-up)
- No cleaning or equilibration required (disposable kit)
- Inventory reduction (tracking individual expiry dates of multiple supplies/standards)
- Process standardization across sites and/or products
- Single sample injection for 10 analyzes
- Reduced risk of radioactive spills and contamination
- Reduced personnel exposure
- Single sample
1. Add the sample and consumables
User installs three consumables and adds the product sample
2. Initiate the analysis
User initiates the analysis using the software
3. Tracer-QC Robot mixes and dispenses the sample
The pipetting robot mixes the sample with specific reagents and dispenses them to the analysis plate.
4. Tracer-QC reader analyzes the optical signals
The reader then analyzes their optical characteristics against a set of predefined and validated reference specifications.
5. Analysis complete
After approximately 30 minutes the analysis is complete.
6. Collect the report
A single page report on up to 10 QC parameters is automatically printed or exported in the desired format.
About Trace-Ability Inc.
Trace-Ability is a growing California-based company that answered the FDA call for modernization of testing technologies in radiopharmaceutical production. Years of experience in PET industry allowed the founders to recognize the opportunity to revolutionize and simplify PET-QC testing using optical techniques. The FDA funding and collaboration have enabled optimization and solid validation of Tracer-QC technology.
The LabLogic/Trace-Ability Partnership
LabLogic Systems have partnered with Trace-Ability Inc. to provide commercial and software development.
This relationship multiples the capabilities offered by each company individually. It allowed Trace-Ability to focus on the technical aspects of bringing Tracer-QC to market. They include development and validation of the core Tracer-QC technology and production of consumables. Meanwhile, LabLogic was able to leverage years of expertise in software development to develop the intuitive user interface backed up by 21 CFR Part 11 compliance. Finally, the hardware platform is uniquely enabled by balancing existing LabLogic and Trace-Ability relationships with analytical and robotic companies.
Commercialization of Tracer-QC is also a joint effort. On one hand, it benefits from the LabLogic’s established global footprint and track record of successfully launching multiple products in the PET radiopharmaceutical field. On the other, it leverages Trace-Ability’s direct ties with industry, KOL’s and regulators. Participation of both companies in commercialization allows the joint product offering to be optimally tuned to each customer’s technical and operational needs.
Tracer-QC-USDownload (8.89 MB)