Radionuclide Laboratory

The Department of Nuclear Medicine and Theranostics has begun its work with the aim of establishing and permanently consolidating the field of nuclear medicine at the Klinikum Ludwigshafen. This includes the radiochemical, quality assurance, and dosimetric structures for diagnostic and, in particular, therapeutic purposes in inpatient and outpatient settings. The procurement measure in question includes, in addition to conceptual planning, an integrated and sustainable infrastructure for theranostic and individualized therapy and outpatient concepts in two expansion stages and will be implemented taking into account the requirements of § 13 AMG. The first expansion stage includes the creation of the infrastructural and technical prerequisites for aseptic preparation under laminar flow conditions and for quality assurance of therapeutically used, commercially available radiopharmaceuticals. A particular focus in this early phase is already on the integration of quality assurance measures and processes. Quality assurance will be implemented as a central component of the workflow from the outset to ensure the safety, traceability, reproducibility, and regulatory compliance of all steps and to enable flexible use of commercially available radiopharmaceuticals in clinical practice. Furthermore, this expansion stage creates the basis for SPECT/CT-based determination of therapy activity with gamma and beta emitters, as well as dosimetric evaluations within the scope of individualized therapies. In the second - optional - expansion stage of the radionuclide laboratory, the radionuclide laboratory will be expanded into a GMP-like infrastructure that is technically and structurally fully compatible with the prerequisites already created in the first expansion stage. The aim is to establish quality-assured processes for the aseptic in-house production and release of radiopharmaceuticals and to expand the therapeutic spectrum through alpha therapies and GMP-compliant individualized treatment concepts. For this purpose, the provision of an isolator with pre-chambers and a synthesis module, as well as an H2O2 generator for aseptic production and filling in clinical routine operation, is planned. The expansion strengthens quality assurance, increases therapeutic flexibility, and enables long-term patient care at the site beyond treatment concepts with commercially available radiopharmaceuticals. The contracting authority reserves the right not to commission the second expansion stage or only to commission it in parts after the first expansion stage. The contractor has no claim to the commissioning of this service. Further services covered by the contract include the planning and conception of both expansion stages, as well as service and maintenance for a period of eight years from the commissioning of the equipment. Construction services are not part of the contract.