The ideal solution for efficient routine production of radiometals
To facilitate the daily work with theranostic tracers, Eckert & Ziegler developed Modular-Lab eazy – the innovative and smallest radiosynthesis system on the market. The synthesizer comes with a completely new cassette design, which makes the handling of Modular-Lab eazy as easy as never before.
With the Modular-Lab eazy module, Eckert & Ziegler developed a very small and compact radiosynthesis module. Combined with the NaCI based labeling procedure and the easy to use cassette based synthesis unit, it allows a fast synthesis and a high throughput production of 68Ga labeled radiopharmaceuticals in the clinical practice.
PhD Michael K. Schultz / Dr. Dirk Müller
Department for Radiochemistry, University Iowa / Zentralklinik Bad Berka, Germany
Modular-Lab eazy works with a technology which uses pressure differences to transfer the liquids instead of solenoid valves or stopcocks. The completely new and innovative cassette design makes the handling of Modular-Lab eazy as easy as never before. By just clicking in the synthesis cassette all pressure connections are done automatically. After connecting the generator and filling the chemicals, the complete synthesis works without user interaction. The process steps can be monitored via the intuitive user interface. The software is based on the established and reliable Modular-Lab Software complying with the highest standards of GMP (annex 11 for computerized systems), GAMP5, 21 CFR 210/211 cGMP and 21 CFR part 11 regulations.
The sterile, disposable cassettes are equipped with a barcode, which can be read by a barcode reader. This feature helps to support the GMP conform production of radiopharmaceuticals through electronic support of batch reporting and prevention of the incorrect use of cassettes.
The synthesis cassettes are assembled under GMP-compliant clean room conditions and sterilized with gamma-radiation (validated process) according to AAMI TIR33/ISO 11137. It comes with all consumables (no chemicals) which are necessary for the specific synthesis and have been tested for their suitability. A shelf-life of 18 months can be guaranteed.
A quick look into the GMP cassette production of Eckert & Ziegler
To be able to start with the production without any further delay, Eckert & Ziegler offers the all-in-one solution for the synthesis, consisting of the registered GalliaPharm® 68Ge/68Ga Generator, [90Y]Yttrium Chloride (Yttriga), disposable synthesis cassettes, quality control devices and a wide range of additional consumables including the Filter Test Module. The peptide has to be purchased by the user.
Users with high demand for 68Ga, e.g. when producing tracers with high specific activities, can now be provided with Eckert & Ziegler Eurotope’s Multi Generator Elution Tool for automated elution of up to three 68Ge/68Ga generators with Modular-Lab eazy.