LabLogic Systems Limited

The Tracer-QC is a completely automated solution to report on 10 QC tests associated with PET and SPECT radiotracers, utilising 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

• Colour
• 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.
• Minimise 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 standardisation across sites and/or products.
• Single sample injection for all analyses.

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.

Logi-CHROM ONE has been developed specifically for PET/SPECT quality control which requires a small footprint and simple to use solution for radiochemical purity testing.

We have used our experience and expertise in supplying radio-HPLC systems to nuclear medicine environments to develop a simple solution with a significantly reduced footprint.

We have combined the most common HPLC modules into one compact system including a Low Pressure Gradient Quaternary Pump, a UV Detector and the Flow-RAM radio detector.

Minimal footprint

Compared to a traditional HPLC system, Logi-CHROM ONE significantly reduces the bench space required for a radio-HPLC unit by 50%.

Cost effective maintenance

Ongoing maintenance costs are reduced − due to fewer parts being used − whilst retaining the same level of functionality as a traditional equivalent system.

Simple set up

Due to its simple design, Logi-CHROM ONE is much easier to set up with limited connections. A smaller, lightweight system also allows for easier changes around a facility compared to a typical HPLC tower.

Integrated into the LabLogic range

Logi-CHROM ONE is part of LabLogic’s expanding range of market leading Radiopharmacy Quality Control solutions. It is fully compatible with Tracer-QC, SPECTra/PETra LIMS and is controlled by Laura for PET radiochromatography software.

A dedicated Laboratory Information Management System, successfully implemented in PET Facilities around the world, PETra is a true PET Laboratory Information Management System (LIMS), designed specifically for use within PET production facilities in order to improve efficiency and compliance.

Since it’s introduction to the market PETra has quickly become an industry favourite following successful installations in some of the world’s most prestigious and regulated PET facilities including Mallinckrodt Institute of Radiology (Washington University, St Louis, USA), Herlev Hospital PET Centre (Copenhagen, Denmark), Memorial Sloan Kettering Cancer Research Centre (New York, USA) and a multi-site deployment at Triad Isotopes (USA).