Tracer-QC

Automated, universal testing for PET-QC

• Color
• Clarity
• pH
• Kryptofix concentration 
• Endotoxin concentration 
• Residual solvents
• Radionuclidic identity (half-life) 
• Radioactivity concentration 
• Radiochemical identity 
• Radiochemical purity
• Chemical purity and specific activity

• 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.

• 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

• 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

Regulatory approval in Europe for ¹⁸F-FDG QC

Following a validation submission by Haukeland University Hospital to the Norwegian Medical Products Agency (DMPA), twelve analytical methods running on the Tracer-QC platform have been approved for the Quality Control of ¹⁸F-FDG intended for clinical use.

DMPA is widely regarded as a highly reputable regulatory authority in Europe. Its endorsement of Tracer-QC methods for supporting the pharmacopeial quality of ¹⁸F-FDG sets an example for other countries following the European Pharmacopeia standards. DMPA complies with the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), as do other authorities in the US and Europe, meaning Tracer-QC analytical methods have met strict international criteria.

You can learn more about this important milestone and what Haukeland's Head of Quality Control Ole Heine Kvernenes had to say about it by clicking the button below.

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Steve Archibald: Why Hull chose to be the first Tracer-QC customer in the UK

Tracer-QC is being installed at the Hull Molecular Imaging Research Center. It is a pioneering Center of Excellence developed in partnership between the University of Hull and Hull University Teaching Hospitals NHS Trust. MIRC houses a dose-on-demand cyclotron and as a combined research and clinical facility, it will deliver superior diagnostics and improved patient outcomes.

In our latest video, we speak to MIRC Director and Professor of Imaging Steve Archibald about how Tracer-QC will allow the center to automate the QC process to produce a greater range of novel radiotracers for cancers, heart disease, and Alzheimer’s.

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Automating ¹⁸F-FDG QC in a live production facility

The IMC is a large tertiary healthcare hospital in Cairo which has been using Tracer-QC to successfully release ¹⁸F-FDG for administration to patients. The facility chose the automated system over traditional QC equipment to release radiotracers to standards as defined by US Pharmacopeia. Its nuclear medicine department has its own PET production facility, including a cyclotron and hot lab, and the hospital has accreditation from the US-based Joint Commission International, recognising the quality and standards of its healthcare at a global level.

We spoke to Sherif Maher of the IMC to find out how Tracer-QC has changed the way he works. Click the button below to find out what he had to say.

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User scans the consumables kit.

User adds the consumables to the Tracer-QC.

User delivers the QC sample in a shielded pig.

Initiate the analysis.

The pipetting robot mixes the sample with specific reagents and dispenses them to the analysis plate.

The reader then analyzes their optical characteristics against a set of predefined and validated reference specifications.

After approximately 30 minutes the analysis is complete.

A single page report on up to 10 QC parameters is automatically printed or exported in the desired format.

• Tracer-Specific Kits Trace-Ability have developed kits that are tried and tested for the release criteria of F-18, C-11 and N-13 radiotracers.
• The kits are available both with or without the HPLC function.

• The majority of the tests available on the Tracer-QC are generic QC tests, which are not tracer specific.
• Universal Kits allow users to run these non-tracer specific tests on any sample.

Research and Development Kits allow users to develop their own kits for QC testing which have not yet been developed by Trace-Ability. Once a kit has been developed, Trace-Ability are able to supply these kits.

Trace-Ability is a growing California-based company that answered the FDA call for modernization of testing technologies in radiopharmaceutical production. Years of experience in PET industry allowed the founders to recognize the opportunity to revolutionize and simplify PET-QC testing using optical techniques. The FDA funding and collaboration have enabled optimization and solid validation of Tracer-QC technology.