- Art
- 16
- Verfahren
- neg-w-call
- Referenznummer
- 196061-2024
- CPV
- 73110000
IRE ELiT is one of the only two global suppliers of germanium-68 (68Ge) / gallium-68 (68Ga) generators approved as a drug in Europe and as an Active Pharmaceutical Ingredient in the United States. More information about …
IRE Elit germanium-68 (68Ge) / gallium-68 (68Ga) radionuclide generator product characteristics can be found on: https://www.ire.eu/medias/295/UK.pdf. Substances that migrate from a container closure system (CCS) into a drug product formulation can potentially affect its safety, stability and effica
cy. Therefore, as part of regulatory compliance, the generator CCS must be assessed for extractables and leachables. Both extractable and leachable reference studies exist for the IRE Elit generator. This procurement notice concerns complem