What tracers can I cover with QC1?

The QC1 system is designed to test any PET tracer. Thanks to its modularity, the system is able to incorporate well established analytical tests and automate them through its software. There is no restrictions in isotopes nor tracers, their specificity can be set in the application.

Which quality controls tests can I do with a QC1 system?

QC1 performs automatically all the quality controls tests typically requested by the different pharmacopeia for PET tracers such as: radiochemical purity (radioTLC and HPLC), gamma ray spectrometry, radionuclidic purity, half-life, radioactivity concentration (volumetric), residual solvents (GC), chemical impurities (HPLC and colour spots), molar activity, specific activity, pH.

How does it work?

The user loads a single use analytical consumable that contains all the components required for the test: the eluents, the cold references, the blanks …

The system recognizes the consumable, upload the dedicated comprehensive method and performs automatically conditioning, injection of blanks and cold references and replicates. The system suitability tests can be scheduled to be performed in a row early in the morning so the samples can be analyzed one after another.

Then from a small volume of sample, the system automatically performs in parallel all the required tests, in compliance with the highest standards of the pharmacopeia.

The final report is immediately issued after completing the last test.

How long does a QC1 run take?

With parallel sample processing the overall process time is defined by the longest analytical process, which in most cases is the radio-HPLC or radio-TLC. The complete process is done in a rather short period of time, which is typically less than 25 minutes for most tracers.

How fast can I switch from one tracer to another?

Within less than 5 minutes the system is up and running for the next operation.

Can I test my own tracers?

The QC1 software allows the user to completely define the methods for a specific tracer linked to a corresponding consumable. In addition to setting the parameters for analysis for each equipment, you can also create a typical workflow: such as system suitability tests with repetitions, blanks, sample analysis, cleanings…

Trasis will provide ready to use, prefilled validated consumables with CoA for most common tracers, depending on customer demands, starting with FDG.

For R&D purposes, empty consumables for individual filling will be available for your own research and for non-standard tracers.

Can I meet my specific requirements with the QC1?

Yes, of course! The QC1 software is able to full-fill routine production and R&D requirements, so if you are in Europe, in US or in Asia you will always be able to define your own criteria to fulfill your local needs. Every single test has its own method that can be customized if needed. All methods for specific tests can be bundled into 1 single method for ease of use, so, once you have defined your global method, it can be used by your operators in few clicks.