A radical and universal new solution for quality control of PET/SPECT 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 single-use consumable kits for release testing of PET/SPECT radiotracers.
- 1 Sample
- 1 Analytical Instrument
- All QC Tests
- 1 Traceable and Objective Report
- Kryptofix concentration
- Endotoxin concentration
- Residual solvents
- Radionuclidic identity (half-life)
- Radioactivity concentration
- Radiochemical identity
- Radiochemical purity
- Chemical purity and specific activity
Benefits to using the Tracer-QC include;
Ease of Compliance
- No chance of missing a process, record or signature.
- Objective measurements traceable to standards, without any human interaction.
- Data flow from measurement to batch record.
- Completely traceable.
- Regular, automated suitability testing with a permanent record.
- Enables FDA 21 CFR Part 11 (Electronic Signatures) and Part 212 (GMP) compliance.
- No cross-contamination with Tracer-QC, as the sample never leaves the disposable kits.
- Ease of (regulatory or internal) audits with instantaneous data retrieval.
- Cumulative annual QC cost reduction of 30% or more.
- Fewer and less skilled personnel required.
- Faster and cheaper training.
- Faster and cheaper audits.
- Electronic access/auditing of records.
- Minimize the cost of addressing 483’s.
- Reduce risk of 483’s by around 84%.
- One analytical instrument to maintain
- 1 electronic report with all QC results, automatically generated.
- Run QC unattended from sample to report.
- Increased throughput to enable scale-up.
- No cleaning or equilibration required with Tracer-QC due to the use of a disposable kit.
- Inventory reduction, eliminating the need to track individual expiry dates of multiple supplies/standards.
- Process standardization across sites and/or products.
- Single sample injection for all analyzes
- Reduced risk of radioactive spills and contamination.
- Reduced personnel exposure.
- Single sample.
- Minimal sample handling with the use of a shielded pig.
- Attenuated exposure.
1. Scan the consumables kit
User scans the consumables kit.
2. Add the consumables to the Tracer-QC
User adds the consumables to the Tracer-QC.
3. Deliver QC sample in a shielded pig
User delivers the QC sample in a shielded pig.
4. Inititate the analysis
Inititate the analysis.
5. Tracer-QC mixes and dispenses the sample
The pipetting robot mixes the sample with specific reagents and dispenses them to the analysis plate.
6. Tracer-QC analysis starts
The reader then analyzes their optical characteristics against a set of predefined and validated reference specifications.
7. Analysis is complete
After approximately 30 minutes the analysis is complete.
8. Collect the report
A single page report on up to 10 QC parameters is automatically printed or exported in the desired format.
- Tracer-Specific Kits Trace-Ability have developed kits that are tried and tested for the release criteria of F-18, C-11 and N-13 radiotracers.
- The kits are available both with or without the HPLC function.
- The majority of the tests available on the Tracer-QC are generic QC tests, which are not tracer specific.
- Universal Kits allow users to run these non-tracer specific tests on any sample.
Research and Development Kits
Research and Development Kits allow users to develop their own kits for QC testing which have not yet been developed by Trace-Ability. Once a kit has been developed, Trace-Ability are able to supply these kits.
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 (7.08 MB)