Trace detector Trace-QC™

opticalprocess

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, utilising 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. Automated. Uncompromised. 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. Cost Reduction 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. Improved Efficiency 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 analyses.