Modular-Lab eazy
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. 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.
Customer review
„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.“
Detail information
Functionality
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.
Cassettes
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.
Take a brief look into our cassette production department here.
Key features
- 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
Recommendation
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.
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. Our newest synthesis system KitLab is a stand-alone device for handling of PET kits and more.
Recent Publications
2021
Pretze M. – Ac-EAZY! Towards GMP-Compliant Module Syntheses of 225Ac-Labeled Peptides for Clinical Application (link)
2020
Spreckelmeyer S – Fully-automated production of [68Ga]Ga-FAPI-46 for clinical application (link)
Caroli P – 68Ga-PSMA-11 PET/CT-Guided Stereotactic Body Radiation Therapy Retreatment in Prostate Cancer Patients with PSA Failure after Salvage Radiotherapy (link)
Børresen B – Noninvasive Molecular Imaging of the Enhanced Permeability and Retention Effect by 64Cu-Liposomes: In vivo Correlations with 68Ga-RGD, Fluid Pressure, Diffusivity and 18F-FDG (link)
de Vries LH – 68Ga-PSMA PET/CT in radioactive iodine-refractory differentiated thyroid cancer and first treatment results with 177Lu-PSMA-617 (link)
Radzina M – Accuracy of 68Ga-PSMA-11 PET/CT and multiparametric MRI for the detection of local tumor and lymph node metastases in early biochemical recurrence of prostate cancer (link)
2018
Van Kalmthout LWM – Impact of external cooling with icepacks on 68Ga-PSMA uptake in salivary glands (link)
Rasmussen T – Angiogenesis PET Tracer Uptake (68Ga-NODAGA-E[(cRGDyK)]2) in Induced Myocardial Infarction and Stromal Cell Treatment in Minipigs (link)
2017
Mueller D – Rapid Synthesis of 68Ga-labeled macroaggregated human serum albumin (MAA) for routine application in perfusion imaging using PET/CT (link)
Eppard E – Optimization of Labeling PSMAHBED with Ethanol-Postprocessed 68Ga and Its Quality Control Systems (link)
Iori M – Labelling of Y- and Lu-DOTA-Bioconjugates for Targeted Radionuclide Therapy: A Comparison among Manual, Semiautomated, and Fully Automated Synthesis (link)
2016
Eppard E – Improved radiolabeling of DOTATOC with trivalent radiometals for clinical application by addition of ethanol (link)
Contact
Eurotope GmbH
Robert-Rössle-Strasse 10
13125 Berlin
Germany
Your contact in US and Canada
Radiopharma, Inc.
25 Upton Drive
Wilmington, MA 01887
USA