Quality Control

QC1

QC1 is a compact and integrated quality control system designed to streamline typical PET tracers QC. Testing your tracer against the most stringent requirements has never been so easy. Although the project is on the rails, QC1 should be available in the mid of 2020.

Compact, Fast and Safe but not only...

  • Standardized quality control operations to enhance reproducibility
  • Comprehensive automated analytical processes
  • Reduced operator dependency and exposure to radiation
  • Modular configuration allows analyzing all known tracers
  • Minimum lab bench preparation
  • Tiny footprint

One sample, One button, One report !

FAQ

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.

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 and chemical purity, 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 card that contains all the components required for the test: the eluents, the cold references, the blanks …

The system recognizes the card, upload the dedicated comprehensive method and performs automatically conditioning, injection of blanks and cold references and replicates.

Then from a small volume of sample, the system automatically performs in parallel all the required tests, in conformance 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.

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

    The team

    The company QC1 GmbH was founded in 2010 with the purpose to develop a small, modular and fully automatic quality control system for PET and molecular imaging tracers: the QC1 system.

    In 2013, QC1 was awarded with an innovation prize for this groundbreaking new concept.

    In 2017, the founders decided to transfer all rights of this development to Trasis to ensure a successful global market introduction. While QC1 GmbH ceases further commercial activities, the name of QC1 will be applied to the product line of quality control systems at Trasis. The initial QC1 team continues working on the industrialization of the system under the lead of Trasis.

    This is the core team as of May 2019 from left to right: Reinhard Grugel, Arthur Vas, Xavier Franci, Alexander Janus, John Witczak, Luc Bolly, Renaud Verdebout.

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