measuring tools for radiationX

Tracer-QC Automated, universal testing for PET-QC

Tracer-QC Automated, universal testing for PET-QC

Ingediend door toon op wo, 03/29/2023 - 19:49

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

  • Color
  • Clarity
  • pH
  • 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.
    • Automated.
    • Uneditable.
    • 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.

Cost Reduction

  • 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

Improved Safety

  • Reduced risk of radioactive spills and contamination.
  • Reduced personnel exposure.
  • Single sample.
  • Minimal sample handling with the use of a shielded pig.
  • Attenuated exposure.