Compact dispensing solutions for sterile filling of radiopharmaceuticals that fit your needs
Dividing radiopharmaceuticals into multi-dose or unit-dose vials
Strictly controlled sterile environments
Sterile manufacturing and filling of radiopharmaceuticals in strictly controlled sterile environments are a crucial requirement outlined in Annex 1 of the EU GMP guidelines. Von Gahlen offers the advantages of automated dose dividing from regular GMP processes to the challenging environments of radiopharmaceuticals.
Challenges when dividing radiopharmaceuticals into small vials
In radiopharmacy, numerous isotopes can be used to diagnose and treat patients. All these different isotopes must be divided into bulk doses or patient-specific doses. Due to the short half-life of most radiopharmaceuticals, efficient aliquoting is essential.
Annex 1 compliance and sterile dosing
Our solutions are GMP Annex 1-compliant for sterile dosing without exposing operators to radiation or compromising process efficiency. The used technology and Von Gahlen’s expertise in shielding and automation come together to ensure consistent quality, reproducibility, and safety in every batch.
Batch production and dosing of pre-sterilized vials
The two dose dividers (Closed Vial Dose Divider – CVDD and Open Vial Dose Divider – OVDD) are specifically designed for the fast dosing of radiopharmaceuticals into multi- or unit-dose vials. The CVDD is our remotely operated solution for dosing with the pierced septum method. During dosing, the ventilated spike pierces the septum of the sterile vial to fill it with the radiopharmaceutical while preventing overpressurization. The OVDD is our remotely operated solution for open vial dosing. The process contains: opening, dosing, capping, and crimping of the pre-sterilized vial. Its ergonomic design requires fewer actions, allowing you to work efficiently. Multiple runs can be performed without waiting for the activity to decay between batches.
Explore the possibilities of our dose dividers
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