DOTATATE

Routine production of radiometals

Features

Introduction

'Gallium labeled components become more widely used for positron emission tomography (PET). The easy and cyclotron independent availability of 'Gallium advances this trend. To facilitate the daily work with 'Gallium, Eckert & Ziegler has developed an innovative and ultra smart radiosynthesis system.

Functionality

The synthesizer works with a new technology* which uses pressure differences to transfer the liquids instead of solenoid valves or stopcocks. Modular-Lab eazy comes with a completely new and innovative 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. 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 GMPcompliant clean room conditions and sterilized with gamma-radiation (validated process) according to AAMI

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
  • System is GMP and GAMP 5 compliant
  • Automatic generating of batch protocols and reports containing all relevant data and information after each run
  • Annual maintenance ensures long operational life

Packages

To be able to start with the production without any further delay, we offer the all-in-one solution for the synthesis of 'Gallium labeled compounds, consisting of "Ge/"Ga Generator, synthesis device, disposable synthesis cassettes, chemical kits and a wide range of additional consumables.

Specifications