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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...
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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...
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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...
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