Nuclear Medicine > LabLogicTracerQC

TracerQC

Automated Universal Testing for PET-QC

 

A radical new universal solution for automated quality control of PET / SPECT radiotracers.

  • Tracer-QC is a fully automated solution for reporting 10 QC tests associated with PET and SPECT radiotracers using only one optical card reader, a pipetting robot and one-time consumable kits for testing PET / SPECT radiotracers.

  • 1 Sample

  • 1 Analytical Instrument

  • All QC Tests

  • 1 Traceable Report and Objective

QC Automatic Tests

  • Color

  • Clarity

  • pH

  • Kryptofix concentration

  • Endotoxin Concentration

  • Residual solvents

  • Radionuclide Identity (Half-Life)

  • Radioactivity Concentration

  • Radiochemical Identity

  • Radiochemical purity

  • Chemical purity and specific activity

Compliance Facility

  • No chance of losing a lawsuit, registration or signature;

  • Traceable objective measurements without any human interaction;

  • Measurement data flow for batch recording:

- Automated;

- Not editable;

- Completely traceable.

  • Regular and automated compliance testing with a permanent record;

  • Enables compliance with 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;

  • Easy auditing (regulatory or internal) with instant data recovery;

 

Cost Reduction

  • Annual cost reduction by 30% or more;

  • Less resources and qualification required;

  • Faster and cheaper training;

  • Faster and cheaper audits;

  • Electronic access / record auditing;

  • Minimizes addressing cost of 483;

  • Reduces the risk of 483 by about 84%;

  • A single analytical instrument;

Higher quality control testing efficiency

  • 1 electronic report with all QC results

  • , automatically generated;

  • Perform unattended sample QC to report;

  • High throughput to allow scaling up;

  • No cleaning or balancing required with Tracer-QC due to use of disposable kit;

  • Inventory reduction, which eliminates the need to track individual due dates from various supplies / patterns;

  • Standardization of processes between sites and / or products;

  • Single sample injection for all analyzes;

 

Enhanced Security

  • Reduction of risk of spills and contamination;

  • Reduced exposure;

  • Single sample;

  • Minimum handling of samples with the use of a shielded container;

  • Attenuated exposure;