Description

Modular-Lab PharmTracer is your solution for efficient routine production of radiopharmaceuticals and research. It uses disposable cassettes containing all the necessary components for a particular synthesis. By customizing the synthesis cassettes and adapting the projects in the software new tracers and processes can easily be developed.

Please note: We have optimized our Modular-Lab PharmTracer for the use of ¹⁸F-Tracers. Software templates and cassettes are available for ¹⁸F-FDG, ¹⁸F-NaF, ¹⁸F-FET, ¹⁸F-FLT, ¹⁸F-FMISO and ¹⁸F-PSMA-1007. For more information please download the overview of available F-18 systems below.

Key features

• Modular Approach for easy extension
• Pre-Validated Processes available
• No Cleaning Routines necessary
• Fully GMP and GAMP5 compliant
• Independent Programming possible
• Easy-To-Operate Interface and software

Detail Information

Introduction

The laboratory equipment Modular-Lab PharmTracer has been specifically designed to allow versatile and efficient routine production of different tracers, complying with GMP requirements. The concept of disposable cassettes enables the user to easily label different radionuclides with the same setup, but without the risk of cross contamination.
The system retains the reliability and versatility of the Modular-Lab Standard system, allowing to make changes in the process as necessary during early-stage development, but then “lock-in” the process for routine production. With this addition, Modular-Lab PharmTracer is the ideal platform for development as well as production of radiopharmaceuticals.

Setup for theranostic tracers and more

The Modular-Lab PharmTracer setup for the labeling of ⁶⁸Ga-, ¹¹¹In-, ¹⁷⁷Lu- and ⁹⁰Y-DOTA peptides will be combined with a Heater Reaction Module (HRM), a Syringe Module (SYM) and, if necessary, with an additional 1-fold Module (SLM-1) when performing the a presure test before the synthesis. Sterile disposable cassettes ensure easy handling by click‘n’start technology. Reagent sets are available. The easy-to-program intuitive graphical interface of the Modular-Lab software is used to control or adapt the synthesis process.

Setup for ¹⁸F tracers

By simply adding modules the setup can be rearranged for use with ¹⁸F tracers. Using the cartridge-based SPE purification approach, the basic Fluorine-18 PharmTracer setup, consisting of the Heater Module (HRM), the Syringe Module (SYM), the 4-fold Module (SLM-4), the 2-fold Module (SLM-2) and a vacuum pump, will enable the production of [¹⁸F]FDG, [¹⁸F]FET, [¹⁸F]FLT, [¹⁸F]FMISO and [¹⁸F]PSMA-1007. A heater and SLM-4 will not be required when producing [¹⁸F]NaF.

Further setups

Further combinations allow the production of ¹¹C, ⁶⁴Cu and many other tracers. More detailed information, e.g. for dispensing, can be provided upon request.

Sterile Disposable Cassettes

All cassettes are assembled under GMP-compliant clean room conditions, sterilized with gamma-radiation and double-vacuum-packed. The consumables used are chemical resistant and have been tested for their suitability with the specific syntheses. Shelf life is validated for up to 18 months under appropriate storage conditions. Cartridges are included and preconditioned automatically if necessary. Due to the cassettes one-time use no cleaning, drying or sanitation routines are necessary.