A radical and universal new solution for automated quality control of PET/SPECT radiotracers.
The Tracer-QC is a completely automated solution to report 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
Automated QC Tests
- 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
Improved Efficiency of Quality Control Tests
- 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.