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Tracer-QC™

Product catalog summary

Introduction
The Tracer-QC™ is an automated solution for quality control (QC) of PET/SPECT radiotracers, utilizing an optical plate reader, pipetting robot, and single-use consumable kits. It ensures compliance with FDA regulations and reduces costs and risks associated with radiopharmaceutical production.

Key Features

Automated and traceable QC process with objective measurements.
Compliance with FDA 21 CFR Part 11 and Part 212.
Reduces cross-contamination and personnel exposure.
Cost reduction in QC processes by 30% or more.
Single analytical instrument for all QC tests.

Improved Safety

Minimized risk of radioactive spills and personnel exposure.
Single sample handling with shielded pig for safety.

Efficiency and Compliance

Automated generation of electronic QC reports.
Increased throughput and process standardization.
Elimination of cleaning and equilibration steps.

Validation and Partnership
Developed in partnership with the FDA, Tracer-QC technology is validated and optimized for radiopharmaceutical QC. LabLogic provides software expertise for compliance and user interface.

QC Tests

Includes tests for color, clarity, pH, endotoxin concentration, radionuclidic identity, and more.

Software and Integration

Compliant software with electronic signatures, audit trails, and direct interface to PETra LIMS.

Service and Support
LabLogic offers comprehensive service and support, including validation services and training to maximize the value of investments in Tracer-QC systems.

Conclusion
The Tracer-QC system provides a streamlined, compliant, and cost-effective solution for PET/SPECT radiotracer quality control, enhancing safety, efficiency, and compliance in radiopharmaceutical production.

Catalog excerpts

Life Sciences Radiation Safety Automated optical testing for PET-QC Now with integrated radio-HPLC

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EXPERIENCE & EXPERTISE A universal new solution for PET/SPECT radiotracer quality control Improved Safety The Tracer-QC is an automated solution that utilises only an optical plate reader, a pipetting robot and single-use consumable kits for release testing of PET/SPECT radiotracers. • Reduced risk of radioactive spills and contamination. • Reduced personnel exposure. • Single sample. • Minimal sample handling with the use of a shielded pig. • Attenuated exposure. About Trace-Ability Inc. Trace-Ability is a growing, California-based company that answered the FDA call for modernisation of testing technologies...

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Automated system for radiopharmaceutical quality control. Tracer-QC rHPLC Automated system with integrated radio-HPLC for radiopharmaceutical quality control. Integrated radio-HPLC Coupling Easy-to-use compliant software The Tracer-QC software enables FDA 21 CFR Part 11 (Electronic Signatures) and Part 212 (GMP) compliance. • Electronic signatures • Audit trail • Access levels • Maintenance records • Automatic reports • Direct interface to PETra LIMS • Export to other 3rd part

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Tracer-Specific Kits 5. Tracer-QC mixes and dispenses the sample 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. 6. Tracer-QC analysis starts 3. Deliver QC sample in a shielded pig Universal Kits Tracer-QC Testing Details Time remaining: Appearance (Clarity) Radioactivity Concentration Radionuclidic Identitiy (Half Life) Super User Radiochemical Purity Universal Kits allow users to run these non-tracer specific tests on any sample. Appearance (Color) The majority...

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Related Products Users of our systems can benefit from our comprehensive, fully inclusive service and support. We can give reassurance that if things go wrong or you need expert advice, help is only an e-mail or phone call away. Validation Services PET/SPECT radio-TLC Scanner PET/SPECT radio-HPLC Detector Our Validation Service enables you to implement and get maximum value from your investments as soon as possible. We work as a partner with your Quality Manager, System Manager and users to provide a tailored Validation Plan, suited to your needs. Our Validation Specialists have years of experience...

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