Reagent medium reagent kit EZ-10 series

for biomolecular imagingfor the pharmaceutical industryquality control

Overview
To facilitate daily handling of 68Ga syntheses, Eckert & Ziegler offers ready-to-use reagent sets designed for KitLab workflows. Each set contains the chemicals and hardware required for a specific synthesis and is manufactured and tested under pharmaceutical-grade quality controls.

Compatibility and use
Designed for use with Modular-Lab PharmTracer and Modular-Lab eazy platforms. The reagent sets are an integral component of 68Ga-HBED-PSMA production when used with KitLab procedures. Additional reagent sets are under development.

Key Features

• Ready-to-use reagent format for streamlined synthesis
• Compatible with Modular-Lab PharmTracer and Modular-Lab eazy
• Bioburden tested chemicals and hardware
• Manufactured to pharmaceutical standards for use in pharmaceutical product production

Safety / Intended Use
The reagent sets are intended for the production of pharmaceutical products by qualified personnel only. They are not intended and not suitable to be used directly and/or unprocessed in humans.

Documentation
Fact sheet available: Fact Sheet Reagent Sets (PDF).

Technical specifications

• Intended radionuclide workflow: 68Ga
• Includes all chemicals and hardware required for the specific synthesis
• Compatible devices: Modular-Lab PharmTracer, Modular-Lab eazy
• Essential for 68Ga-HBED-PSMA production with KitLab
• Manufacturing standard: ICH Q7A – GMP standards for APIs; manufactured according to GMP requirements
• Chemicals and hardware tested for bioburden
• Ready-to-use reagent format
• Designed for pharmaceutical product production
• Intended for use by qualified personnel only; not for direct/unprocessed use in humans
• Further reagent sets under development