To facilitate the daily work with Theranostics 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. 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.
„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, Department for Radiochemistry, University Iowa
Dr. Dirk Müller, 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.
- Smallest radiosynthesizer on the market – one module with complete functionality
- Short synthesis time and easy handling
- High yield and high radiochemical purity
- Highest product quality through sterile and disposable synthesis cassettes (validated sterilization method incl. shelf-life)
- Pre-defined software template with easy-to-operate user interface
- GMP and GAMP 5 compliance
- Automatic generating of batch protocols and reports containing all relevant data and information after each run
- Annual maintenance to ensure long operational life
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, ready-to-use reagent kits, quality control devices and a wide range of additional consumables. 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.
Eckert & Ziegler also offers alternatives from the Modular-Lab family. Modular-Lab Standard is a tubing-based system intended for research and development of radiotracers. Modular-Lab PharmTracer follows the cassette-based approach and can be used for GMP-compliant routine production as well as research purposes.
Multi Generator Elution Tool
Multi Generator Elution Tool For Modular-Lab eazy
Automated elution of up to three 68Ge/68Ga generators with only one synthesizer.
The increasing acceptance and demand for 68Gallium for use in the development of diagnostic imaging kits, as well as in actual clinical practice, has highlighted some shortcomings with the existing radiolabeling systems. The trend towards the need for higher activity generators aggravates the potential extremity dose received during manual radiolabeling proto-cols, as well as increasing the incorporated shielding required and therefore the weight of the generators.
In light of these trends, Eckert & Ziegler has developed the Multi Generator Elution Tool. This new tool enables the automated use of eluate from up to three standard (each max. 1.85 GBq/50 mCi) 68Ge/68Ga generators for a single production process with the Modular-Lab eazy system. Sites with high demand for 68Gallium will now be able to combine the required 68Ge activity from one, two or three generators in a single-step procedure. Furthermore, the tool can extend the useful life of each generator by combining eluates.
The Multi Generator Elution Tool updates the current available activity within each of the generators so the user only needs to enter the required amount of activity via the included software tool. The tool automatically calculates the theoretically available activity in each referenced generator, based on the date of its previous elution. The tool furthermore gives recommendation as to which generator(s) should be eluted in order to provide the requested activity. Users can either accept or manually select another option.
•Flexibility to use low and high activities
•Extension of the period of use for each generator by combining eluates of the generators
•Opportunity to produce tracers with high specific activities
•Multi-dose or various single-doses with high activities - in only one production process
•Automatic calculation of which generators have to be eluted and in which order
•Possibility to view each generator‘s current acitivity
Validated with the following 68Ge/68Ga
Standard time of elution for each 68Ge/68Ga generator:
(time is adjustable, depending on the lengh of tubing)
with one 68Ge/68Ga generator: < 14 min
with two 68Ge/68Ga generators: < 17 min
with three 68Ge/68Ga generators: < 19 min
Available for the following applications:
68Ga DOTA- conjugated peptides
Stopcock Cassette Module (SLM-1), BUS cable, corresponding software
Elution cassette, multiple use / max. 20 elutions (Art. No. C1-GA68-MULTI)
Waste vial with septum, ≥ 30 mL, multiple use
The end user is solely responsible when using high activities for radiolabeling and should be aware that such high activities might bear the risk of radiolytic decomposition of the tracer after a certain period of time. The use of high activity levels has not been validated for radiolytic effects. No warranty is given by Eckert & Ziegler Eurotope GmbH.