FEBO Series – Syringe Dispensing System

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FEBO Series Syringe Dispensing System are designed for safe and accurate fractionation of radiopharmaceuticals in syringes. The FEBO Series was designed in compliance with Eudralex requirements – Volume 4 Good Manufacturing Practice (GMP) Guidelines. Its goal is to introduce a fast and efficient dose preparation process in Nuclear Medicine and Radiopharmacy departments.

These dispensers are reliable as normal dose calibrators as they can measure the radioactivity of the dispensed dose through an integrated ionising chamber.

FEBO can receive radiopharmaceuticals from a multidose vial and are designed to be installed inside laminar flow cells, isolators or hoods.

The FEBO-NM (Nuclear Medicine) Syringe Dispensing System configuration is mainly intended for Nuclear Medicine departments. It is equipped with shielding for single-use kit lines and for target syringe/cartridges. It is suitable for dispensing of activities normally manipulated in these departments for diagnostic and therapeutic purposes and can be placed in shielded cells  or in laminar flow hoods. This configuration entails reception of the radiopharmaceutical already sterilised.

The FEBO-RP (RadioPharmacy) Syringe Dispensing System configuration is mainly intended for Production and Radiopharmacy departments. It is equipped with in-line sterilising filter, it sterilises the radiopharmaceutical before dispensing in target syringe as required for production from synthesis module. The absence of shielding makes the machine suitable to be used with tele-pliers and allows it to be positioned in shielded isolators. The single-use kit is installed and removed manually.

Dispensing Process

Based on a user set bulk concentration, the integrated dispensing pump will push a volume into the system ionization chamber and the actual activity of this dose is measured.
In a next step the system will pump the dose into a pre-shielded syringe followed by a small volume of saline to flush the line. The first syringe is dispensed using the entered concentration data. The accuracy of this first syringe is determined by the accuracy of this user set concentration. For the next syringe, the system software will automatically re-calculate the Bulk concentration and use this actual concentration instead of the user set concentration.

Highlights of syringe dispensing system

• Dispensing in 5 and 10 ml syringes
• Integrated ionization chamber
• Suitable for shielded isolator or open hood
• Suitable for Nuclear Medicine departments and for Production and Radiopharmacy departments
• Sterile disposable cassette
• Its compact size allows installation in cells with small working areas
• Possibility of using it without external dose calibrator
• High ergonomics to facilitate loading/unloading of syringes and disposables
• Sterile disposable for dilution, dispensing and washing
• Process checks by active sensor detection
• It does not require pneumatic supply
• Use of materials perfectly compatible with the most common sterilisation procedures such as hydrogen peroxide in the vapour state (VPHP)
• Recipe management, automation and workflow control by means of operator interface developed in accordance with GAMP regulation and compliant with 21 CFR Part 11.