Advanced Integrated Solution for Quality Control of Radiolabelled Compounds
At Med I Thailand, we are proud to work with Elysia Raytest to bring their new QC-Cubicle—an all-in-one quality control lab to the Thai market for radiopharmaceutical production. The next-generation QC lab saves time and space and optimizes safety.
The QC-Cubicle is equipped with all hardware needed for the Quality Control of 18F-FDG in agreement with European Pharmacopeia standards; it is versatile enough to be easily adapted or extended towards other tracers.
To maximize space efficiency and provide optimal workflows, QC-Cubicle has been designed to allow a complete QC process within a laboratory space of less than two m². Intuitive operation is reached by a user-friendly interface complemented by a big touch screen.
Each integrated instrument module is a high-grade product; thus, it provides a robust and flexible solution that can be easily integrated with more tracers and adapted to new rules and regulations. First-class protection against radiation, better than standard QC solutions, large UPS to ensure not even disturbances in QC operations occur because of power failure, increase in shielding, and in-built waste control.
The system cuts down on operation expenses since the gas requirements and connections are optimized to make it easier for installations and maintenance. Critical LIMS solutions for all essential QC-Cubicles are Gina X and Sara. Additionally, the QC-Cubicles can be upgraded into a fully functional LIMS Solution: BIOTRAX LIMS, covering advanced laboratory management integrated with stock and document management. The solution is such that the BIOTRAX LIMS manages the whole system, including SOPs, instruments, data, results, consumables, workflows, and documentation resources, etc.
The QC-Cubicle performs well, efficiently operating and processing data of the results from each device for documentation and reporting. This reduces the complexity for users with automatic workflow support and better radiation protection and saves valuable time. Offers a range of QC-Cubicles optimized for radiopharmaceuticals: flexibility is at its maximum, which allows adding other modules in the future if other tracers require it.
LIMS Reporting
GINA X with the Raphaela module is a database based LIMS system. The acquisition, recording and reporting of results from individual instruments has never been easier, making the data recording and management of a radiopharmaceutical quality control simpler and fully traceable.
The system automatically – and digitally – records the information required by authorities for the release of a radiopharmaceutical tracer.
PH Strip Reader
Automatic pH strip reader for fast, easy and reliable pH determination. This reader offers an objective way to read pH test strips – simplifying testing procedures, reducing the radioactive sample volume, standardizing the decision processes by eliminating the subjectivity of visual readings and allowing a safe and digital data transfer.
Endotoxin Test
This makes it the best solution for the determination of endotoxins in radiopharmaceuticals. FDA-approved disposable cartridges make use safe and easy.
It gives LAL results within fifteen minutes. There are four sensitivities to pick from: 0.005, 0.01, 0.05, and 0.10 EU/ml.
For that, you don’t need any kind of training in microbiology. Just anyone can run this simple assay.
Radio HPLC
The Radio-HPLC is dedicated to the best performance and price-performance ratio for the QC of FDG.
The ideal combination in the pump, type of detector, software solution, and radioprotection is available. This system includes everything needed to carry out HPLC testing according to the European Pharmacopoeia for 18F-FDG.
Furthermore, this radio detector is sensitive yet retains resolution.
Gas Chromatography
Elysia devised a best-in-class GC solution for residual solvent measurement with the highest precision in a radiopharmaceutical QC lab. Better arguments are added to this, like higher radioprotection, low sample volumes, and short analysis times in case work has to be done with isotopes. The automatic injector allows better safety in handling and repeatability with low hands-on time.
Gamma Spectreometer
Our desktop-integrated Cubicle has a multi-channel analyzer. The thick shielding is integrated together with the detector for high-speed spectroscopic analyses of your QC samples. It is perfect for the determination of shallow activities or radionuclide impurities. Intuitive manipulation is made simple by live spectrum display, selectable nuclide ROIs, and automatic energy calibration.
Gamma Spectreometer
This is an in-built software-controlled Dose Calibrator to give results for the activity or volumetric activity of radiopharmaceuticals used in nuclear medicine for both diagnosis and therapy purposes. It is calibrated for all the common radionuclides, including the RSO and PET nuclides. Integrated in the desktop with additional shielding, it holds a CE mark as a medical device according to European legislation, class IIb.
Radio TLC
This scanner features a state-of-the-art radio-TLC system. Thanks to a complete line of detector probes, it is possible to make measurements for nearly every isotope. It is specially designed for nuclear medicine, SPECT, or PET laboratories. It has superior detection, excellent signal-to-noise ratio, and optimal spatial signal resolution. The moving sample table saves space, and the integration into the desktop permits automatic adaptation of the acquisition time to the sample’s radiation.
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